144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details
臨床試験数 : 101 / 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-002482-17-GR (EUCTR) | 17/03/2022 | 24/01/2022 | Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes | A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). | Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT | Takeda Development Center Americas, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 376 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan | ||
| 2 | NCT05163314 (ClinicalTrials.gov) | March 6, 2022 | 15/12/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2) | Dravet Syndrome (DS);Lennox Gastaut Syndrome (LGS) | Drug: Soticlestat | Takeda | NULL | Not yet recruiting | 2 Years | 36 Years | All | 376 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 3 | EUCTR2021-002481-40-BE (EUCTR) | 20/12/2021 | 12/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Japan;China;Latvia;Netherlands;Australia;Belgium;Poland;Canada;Hungary;France;Italy;United Kingdom;Russian Federation;Ukraine;Spain;Greece;United States;Serbia | ||
| 4 | EUCTR2021-002481-40-NL (EUCTR) | 04/11/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan | ||
| 5 | EUCTR2021-002481-40-HU (EUCTR) | 22/10/2021 | 25/10/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 6 | EUCTR2021-002481-40-PL (EUCTR) | 20/10/2021 | 17/09/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 7 | EUCTR2021-002481-40-IT (EUCTR) | 12/10/2021 | 27/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) - Skyway | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: [TAK-935] INN or Proposed INN: Soticlestat Product Name: Soticlestat Product Code: [TAK-935] INN or Proposed INN: Soticlestat | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 8 | EUCTR2021-002481-40-ES (EUCTR) | 05/10/2021 | 30/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 9 | NCT04938427 (ClinicalTrials.gov) | September 29, 2021 | 18/6/2021 | A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox Gastaut Syndrome (LGS) | Drug: Soticlestat;Drug: Placebo | Takeda | NULL | Recruiting | 2 Years | 35 Years | All | 234 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 10 | JPRN-jRCT2051210073 | 29/09/2021 | 04/09/2021 | A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome | Soticlestat Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, orally or via gastrostomy tube (G-tube) or percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) based on the body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the Titration Period, for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment. Participants weighing >=45 kg: Soticlestat mini-tablets or tablets with a starting dose of 100 mg BID followed by 200 mg BID and, then 300 mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300 mg BID for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment. Placebo Soticlestat placebo-matching mini-tablets or tablets, orally or via G-tube or PEG tube, BID, up to 4 weeks in the Titration Period. Participants will continue to receive the soticlestat placebo-matching mini-tablets or tablets for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks. Soticlestat matching tapering will be done to maintain the blind if participants decide to discontinue the treatment. | Nonomura Hidenori | NULL | Recruiting | >= 2age old | <= 35age old | Both | 234 | Phase 3 | China,;Korea;Spain;Ukraine;United States;Russia;Serbia;Belgium;France;Greece;Hungary;Italy;Latvia;Poland,;Netherlands;United Kingdom;Australia;Canada;Japan |
| 11 | EUCTR2021-002481-40-GR (EUCTR) | 22/09/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 12 | NCT05044819 (ClinicalTrials.gov) | July 7, 2021 | 30/8/2021 | Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | Lennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis Complex | Drug: Cannabidiol | GW Research Ltd | NULL | Recruiting | 1 Year | N/A | All | 150 | Phase 4 | United States |
| 13 | NCT04133480 (ClinicalTrials.gov) | October 2020 | 17/10/2019 | Investigation of Cognitive Outcomes With Cannabidiol Oral Solution | An Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P) | Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Withdrawn | 3 Years | 10 Years | All | 0 | Phase 4 | United States |
| 14 | EUCTR2019-001331-31-SE (EUCTR) | 17/06/2020 | 08/01/2020 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 15 | EUCTR2019-001331-31-DE (EUCTR) | 07/04/2020 | 13/11/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 16 | NCT04611438 (ClinicalTrials.gov) | March 30, 2020 | 16/9/2019 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: Cannabidiol | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 107 | Phase 3 | Korea, Republic of |
| 17 | EUCTR2019-001331-31-NL (EUCTR) | 12/03/2020 | 04/02/2020 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 18 | EUCTR2019-001331-31-DK (EUCTR) | 17/01/2020 | 26/09/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden | ||
| 19 | EUCTR2019-001331-31-IT (EUCTR) | 18/12/2019 | 17/06/2021 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With EpilepticEncephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy forSeizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome - - | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramina cloridrato Product Code: [ZX008] INN or Proposed INN: Fenfluramina cloridrato Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 20 | EUCTR2019-001331-31-FR (EUCTR) | 13/12/2019 | 16/10/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden | ||
| 21 | EUCTR2019-001331-31-ES (EUCTR) | 10/12/2019 | 06/11/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 22 | EUCTR2019-001331-31-GB (EUCTR) | 07/11/2019 | 29/08/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 23 | EUCTR2018-002485-39-PL (EUCTR) | 13/08/2019 | 07/05/2019 | A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION) | A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION) | developmental and epileptic encephalopathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: Soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: Soticlestat | Ovid Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 2 | Portugal;United States;Canada;Spain;Poland;Australia;Israel;China | ||
| 24 | JPRN-jRCT2041200096 | 07/05/2019 | 29/01/2021 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS) | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS) ; Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut syndrome | ZX008 (Fenfluramine Hydrochloride) Oral Solution 0.2 - -.8 mg/kg. max 30mg/day | YAMAMOTO Hideichiro | NULL | Not Recruiting | >= 2age old | <= 35age old | Both | 300 | Phase 3 | Canda;US;Mexico;Belgium;Denmark;France;Germany;Italy;Netherland;Spain;Sweeden;Poland;Australia;Japan |
| 25 | NCT04062981 (ClinicalTrials.gov) | May 3, 2019 | 30/5/2019 | Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Carisbamate | SK Life Science, Inc. | NULL | Recruiting | 2 Years | N/A | All | 30 | Phase 1 | United States |
| 26 | NCT03936777 (ClinicalTrials.gov) | April 22, 2019 | 12/4/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome;Epileptic Encephalopathy | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix, Inc. | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Enrolling by invitation | 2 Years | N/A | All | 650 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Mexico;Netherlands;Poland;Spain;Sweden;United Kingdom |
| 27 | NCT03731715 (ClinicalTrials.gov) | February 7, 2019 | 16/10/2018 | Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome | Phase I, Open-Label, Pharmacokinetic, Dose Escalation Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Carisbamate | SK Life Science, Inc. | NULL | Recruiting | 2 Years | N/A | All | 24 | Phase 1 | United States |
| 28 | EUCTR2017-002628-26-SE (EUCTR) | 21/01/2019 | 29/05/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 29 | NCT03778424 (ClinicalTrials.gov) | January 9, 2019 | 27/11/2018 | An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 | An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Rufinamide | Eisai Inc. | NULL | Available | 4 Years | N/A | All | Poland | ||
| 30 | EUCTR2017-002628-26-DE (EUCTR) | 15/11/2018 | 11/04/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 31 | EUCTR2017-002628-26-FR (EUCTR) | 09/11/2018 | 14/08/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 32 | EUCTR2017-002628-26-NL (EUCTR) | 24/09/2018 | 06/06/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 33 | NCT03650452 (ClinicalTrials.gov) | August 8, 2018 | 27/8/2018 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: TAK-935;Drug: Placebo | Takeda | Ovid Therapeutics Inc. | Completed | 2 Years | 17 Years | All | 141 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 34 | EUCTR2017-002628-26-BE (EUCTR) | 23/07/2018 | 30/03/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 35 | NCT03635073 (ClinicalTrials.gov) | July 19, 2018 | 6/8/2018 | A Study of Soticlestat in Adults and Children With Rare Epilepsies | A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1) | Epilepsy;Dravet Syndrome (DS);Lennox-Gastaut Syndrome (LGS) | Drug: Soticlestat | Takeda | NULL | Active, not recruiting | 2 Years | N/A | All | 156 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 36 | EUCTR2017-002628-26-IT (EUCTR) | 16/07/2018 | 25/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 37 | EUCTR2017-002628-26-DK (EUCTR) | 09/07/2018 | 17/05/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Sweden;Japan;Netherlands;Germany;Norway;Australia;Denmark;Belgium;Poland;Canada;Mexico;France;Italy;United Kingdom;Israel;Austria;Spain;United States | ||
| 38 | EUCTR2017-002628-26-ES (EUCTR) | 12/06/2018 | 20/04/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 39 | EUCTR2014-002321-35-BE (EUCTR) | 05/06/2018 | 25/04/2017 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | ||
| 40 | NCT03254680 (ClinicalTrials.gov) | March 2018 | 15/8/2017 | Turmeric as Treatment in Epilepsy | Turmeric as Treatment in Epilepsy | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal Seizures | Dietary Supplement: Turmeric | NYU Langone Health | NULL | Withdrawn | 1 Year | 70 Years | All | 0 | N/A | United States |
| 41 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol | An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 to 0.8 mg/kg/day;Drug: Cannabidiol | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 18 Years | All | 9 | Phase 1/Phase 2 | United States |
| 42 | NCT02318537 (ClinicalTrials.gov) | December 30, 2017 | 12/12/2014 | Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Cannabidiol Oral Solution;Drug: Placebo Solution | INSYS Therapeutics Inc | NULL | Withdrawn | 2 Years | 30 Years | All | 0 | Phase 3 | NULL |
| 43 | NCT03355209 (ClinicalTrials.gov) | November 27, 2017 | 19/6/2017 | A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome | A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS | Lennox Gastaut Syndrome | Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 35 Years | All | 296 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria |
| 44 | EUCTR2014-002321-35-IT (EUCTR) | 01/09/2017 | 20/01/2022 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness inpatients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With anOpen-Label Extension Phase of Perampanel as Adjunctive Treatment inSubjects at Least 2 years of Age With Inadequately Controlled SeizuresAssociated With Lennox-Gastaut Syndrome - - | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa INN or Proposed INN: PERAMPANEL Other descriptive name: PERAMPANEL Trade Name: Fycompa INN or Proposed INN: PERAMPANEL Other descriptive name: PERAMPANEL | EISAI LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;Czechia;Korea, Democratic People's Republic of;Lithuania;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of | ||
| 45 | EUCTR2014-002321-35-CZ (EUCTR) | 31/08/2017 | 26/05/2017 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of | ||
| 46 | EUCTR2014-002321-35-LV (EUCTR) | 26/05/2017 | 09/05/2017 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | ||
| 47 | EUCTR2014-002321-35-HU (EUCTR) | 08/05/2017 | 20/04/2017 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 19.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | ||
| 48 | NCT02815540 (ClinicalTrials.gov) | February 16, 2017 | 20/6/2016 | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children | Lennox-Gastaut Syndrome;Dravet Syndrome | Procedure: 12-Lead ECG;Drug: Cannabidiol | Gillette Children's Specialty Healthcare | NULL | Terminated | 2 Years | 30 Years | All | 2 | Phase 1/Phase 2 | United States |
| 49 | JPRN-JapicCTI-173536 | 13/12/2016 | 15/03/2017 | Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome (LGS) | Intervention name : E2007 INN of the intervention : Perampanel Dosage And administration of the intervention : 2 mg oral tablets and 0.5 mg/ml oral suspension Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Matching-placebo | Eisai Co., Ltd. | NULL | complete | 2 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, Europe, Oceania | |
| 50 | NCT02834793 (ClinicalTrials.gov) | December 13, 2016 | 13/7/2016 | Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome (LGS) | Drug: Placebo;Drug: Perampanel | Eisai Inc. | NULL | Terminated | 2 Years | N/A | All | 70 | Phase 3 | Czechia;India;Japan;Korea, Republic of;Australia;Belgium;United States;Austria |
| 51 | NCT02655198 (ClinicalTrials.gov) | January 2016 | 12/1/2016 | Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy | Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy | Epilepsy;Lennox Gastaut Syndrome | Drug: Fenfluramine | KU Leuven | Zogenix, Inc. | Active, not recruiting | 3 Years | 18 Years | All | 13 | Phase 2 | Belgium |
| 52 | EUCTR2014-002941-23-NL (EUCTR) | 30/09/2015 | 31/03/2015 | Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syndrome in children and adults | Lennox-Gastaut syndrome MedDRA version: 19.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Poland;Netherlands | |||
| 53 | EUCTR2014-001834-27-NL (EUCTR) | 09/09/2015 | 18/06/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 54 | EUCTR2014-001834-27-FR (EUCTR) | 03/09/2015 | 20/07/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 530 | Phase 3 | United States;France;Spain;Poland;Israel;Netherlands;United Kingdom | ||
| 55 | EUCTR2014-001834-27-PL (EUCTR) | 18/08/2015 | 14/05/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 56 | NCT02307578 (ClinicalTrials.gov) | August 2015 | 2/12/2014 | An Extended Access Program (EAP) for Perampanel | An Extended Access Program (EAP) for Perampanel | Primary Generalized Tonic-Clonic or Partial Onset Seizures;Lennox Gastaut Syndrome | Drug: Perampanel | Eisai Inc. | NULL | Available | 1 Year | N/A | All | Poland;Spain;Belgium;Chile;Estonia;Hungary;Latvia;Lithuania | ||
| 57 | EUCTR2014-002940-42-GB (EUCTR) | 28/07/2015 | 26/09/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. | Lennox-Gastaut syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Spain;United Kingdom | ||
| 58 | EUCTR2014-002941-23-PL (EUCTR) | 16/07/2015 | 01/04/2015 | Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adults | A randomized, double-blind, placebo-controlled study toinvestigate the efficacy and safety of cannabidiol (GWP42003-P;CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults | Lennox-Gastaut syndrome MedDRA version: 18.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Poland;Netherlands | ||
| 59 | NCT02224560 (ClinicalTrials.gov) | June 8, 2015 | 21/8/2014 | Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. | Epilepsy;Lennox Gastaut Syndrome | Drug: GWP42003-P;Drug: Placebo control | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 225 | Phase 3 | United States;France;Spain;United Kingdom |
| 60 | NCT02224573 (ClinicalTrials.gov) | June 2015 | 21/8/2014 | GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes | An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes. | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 2 Years | N/A | All | 681 | Phase 3 | NULL |
| 61 | EUCTR2014-001834-27-ES (EUCTR) | 21/05/2015 | 14/04/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 430 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Poland;Spain;Israel;Netherlands;United Kingdom | ||
| 62 | NCT02224690 (ClinicalTrials.gov) | April 28, 2015 | 21/8/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. | Epilepsy;Lennox-Gastaut Syndrome | Drug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 171 | Phase 3 | United States;Netherlands;Poland |
| 63 | EUCTR2014-002940-42-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. | Lennox-Gastaut syndrome (LGS) MedDRA version: 17.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;United Kingdom | ||
| 64 | EUCTR2014-001834-27-GB (EUCTR) | 14/01/2015 | 30/09/2014 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 680 | Phase 3 | France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 65 | NCT02175173 (ClinicalTrials.gov) | June 13, 2013 | 10/6/2014 | Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 728 | Japan | ||
| 66 | JPRN-JapicCTI-132169 | 29/5/2013 | 21/06/2013 | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Lennox-Gastaut syndrome | Intervention name : Inovelon INN of the intervention : Rufinamide Dosage And administration of the intervention : Oral Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Eisai Co., Ltd. | NULL | recruiting | BOTH | 300 | NA | Japan | ||
| 67 | NCT01668654 (ClinicalTrials.gov) | September 4, 2012 | 17/5/2012 | Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS | RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects With Partial Onset Seizures (>= 12 Years Old) and Subjects With Lennox-Gastaut Syndrome (>=12 Years Old) | Epilepsy | Drug: retigabine/ezogabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 29 Years | All | 4 | Phase 3 | United States |
| 68 | EUCTR2010-023505-36-GR (EUCTR) | 08/08/2012 | 08/08/2012 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Greece;South Africa;Italy | |||
| 69 | NCT01494584 (ClinicalTrials.gov) | July 25, 2012 | 1/12/2011 | Study in Pediatric Subjects With Epilepsy | Open-label, Multiple Dose Study to Evaluate the Parmacokinetics, Safety and Tolerability of Ezogabine/Retigabine as Adjunctive Treatment in Subjects Aged From 12 Years to Less Than 18 Years With Partial Onset Seizures or Lennox-Gastaut Syndrome | Epilepsy | Drug: ezogabine/retigabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 17 Years | All | 5 | Phase 2 | United States |
| 70 | EUCTR2010-023505-36-IT (EUCTR) | 29/09/2011 | 05/01/2012 | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome - E2080-G000-303 | Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Other descriptive name: Rufinamide oral suspension INN or Proposed INN: lamotrigine Other descriptive name: Lamictal INN or Proposed INN: sodio valproato INN or Proposed INN: topimarato Other descriptive name: topimarate | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 75 | Greece;Italy | |||
| 71 | NCT01370486 (ClinicalTrials.gov) | August 2011 | 8/6/2011 | Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects | Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects | Lennox-Gastaut Syndrome | Drug: melatonin;Drug: placebo | Institution de Lavigny | NULL | Not yet recruiting | 18 Years | 55 Years | Both | 6 | Phase 4 | Switzerland |
| 72 | NCT01405053 (ClinicalTrials.gov) | June 16, 2011 | 27/7/2011 | Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide;Drug: Any other approved Antiepileptic Drug | Eisai Inc. | NULL | Completed | 1 Year | 3 Years | All | 37 | Phase 3 | United States;Canada;France;Greece;Italy;Poland;South Africa;India |
| 73 | NCT01151540 (ClinicalTrials.gov) | November 2010 | 14/6/2010 | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Completed | 4 Years | 30 Years | All | 54 | Phase 3 | Japan |
| 74 | NCT01146951 (ClinicalTrials.gov) | June 2010 | 14/6/2010 | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide (E2080);Drug: Placebo | Eisai Limited | NULL | Completed | 4 Years | 30 Years | All | 66 | Phase 3 | Japan |
| 75 | EUCTR2007-004350-82-BG (EUCTR) | 10/11/2008 | 13/11/2008 | Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome - | Lennox-Gastaut syndrome MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome | Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 5mg INN or Proposed INN: CLOBAZAM Other descriptive name: Clobazam PhEur Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 10mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam PhEur Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 20mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam Pheur | Ovation Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
| 76 | EUCTR2007-004322-24-BG (EUCTR) | 28/10/2008 | 03/11/2008 | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. | Lennox-Gastaut Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome | Trade Name: Clobazam Product Name: Clobazam Tablets 5mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam PhEur | Ovation Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
| 77 | EUCTR2007-004322-24-LT (EUCTR) | 17/03/2008 | 21/01/2008 | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. | Lennox-Gastaut Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome | Trade Name: Clobazam Product Name: Clobazam Tablets 5mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam PhEur | Lundbeck Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
| 78 | EUCTR2007-004350-82-LT (EUCTR) | 17/03/2008 | 21/01/2008 | Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome - | Lennox-Gastaut syndrome MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome | Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 5mg INN or Proposed INN: CLOBAZAM Other descriptive name: Clobazam PhEur Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 10mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam PhEur Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 20mg INN or Proposed INN: Clobazam Other descriptive name: Clobazam Pheur | Lundbeck Inc | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
| 79 | NCT00518713 (ClinicalTrials.gov) | August 2007 | 20/8/2007 | Clobazam in Patients With Lennox-Gastaut Syndrome | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam Medium Dose;Drug: Clobazam High Dose;Drug: Placebo | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 238 | Phase 3 | United States;Australia;Belarus;India;Lithuania;Serbia |
| 80 | NCT01160770 (ClinicalTrials.gov) | December 2005 | 18/6/2010 | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Clobazam | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 267 | Phase 3 | NULL |
| 81 | NCT00162981 (ClinicalTrials.gov) | October 2005 | 9/9/2005 | Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam High Dose | Lundbeck LLC | NULL | Completed | 2 Years | 30 Years | All | 68 | Phase 2 | United States |
| 82 | NCT00297349 (ClinicalTrials.gov) | November 2003 | 24/2/2006 | A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures | An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older | Seizures;Epilepsy | Drug: Topiramate | Janssen Cilag Pharmaceutica S.A.C.I., Greece | NULL | Completed | 2 Years | N/A | Both | 153 | N/A | NULL |
| 83 | NCT00004776 (ClinicalTrials.gov) | November 1993 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: topiramate | National Center for Research Resources (NCRR) | University of California, Los Angeles | Completed | 4 Years | 30 Years | Both | 10 | Phase 3 | NULL | |
| 84 | NCT00236756 (ClinicalTrials.gov) | August 1993 | 7/10/2005 | A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome | A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome. | Epilepsy;Seizures | Drug: topiramate | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 12 Months | 30 Years | Both | 100 | Phase 3 | NULL |
| 85 | EUCTR2016-004953-34-Outside-EU/EEA (EUCTR) | 23/02/2017 | A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome | A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome | Lennox-Gastaut Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Product Name: rufinamide Product Code: E2080 INN or Proposed INN: RUFINAMIDE | Eisai Co, Ltd. | NULL | NA | Female: yes Male: yes | 54 | Phase 3 | Japan | |||
| 86 | EUCTR2017-002628-26-GB (EUCTR) | 22/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | NA | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 87 | EUCTR2010-023505-36-FR (EUCTR) | 19/05/2011 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 13.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;France;Greece;Italy;India | |||
| 88 | EUCTR2012-001132-60-Outside-EU/EEA (EUCTR) | 09/03/2012 | Study in pediatric subjects with epilepsy | Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Potiga Product Name: Retigabine/Ezogabine Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 16 | United States | ||||
| 89 | EUCTR2019-001331-31-BE (EUCTR) | 26/09/2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 90 | EUCTR2017-002628-26-PL (EUCTR) | 21/08/2018 | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 91 | EUCTR2021-002481-40-LV (EUCTR) | 02/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 92 | EUCTR2021-002481-40-Outside-EU/EEA (EUCTR) | 22/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | Phase 3 | Australia;Canada;China;Japan;Russian Federation;Serbia;Ukraine;United States;Belgium;France;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Spain;United Kingdom | ||||
| 93 | EUCTR2014-002321-35-PL (EUCTR) | 13/05/2017 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Latvia;Japan;Italy;Korea, Republic of | |||
| 94 | EUCTR2010-020154-33-Outside-EU/EEA (EUCTR) | 09/03/2012 | Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy | RTG113388, a Long-term, Open-label Safety Extension Study ofRetigabine/Ezogabine in Pediatric Subjects with Partial OnsetSeizures(=12 years old) and Subjects with Lennox-GastautSyndrome (=12 years old) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGS | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Trade Name: Potiga Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US only) Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 500 | United States | ||||
| 95 | EUCTR2010-023505-36-Outside-EU/EEA (EUCTR) | 13/02/2017 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 19.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;Canada | |||
| 96 | EUCTR2021-002481-40-FR (EUCTR) | 29/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) | Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: Soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 97 | EUCTR2017-002628-26-AT (EUCTR) | 16/05/2018 | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS | Lennox-Gastaut Syndrome in Children and Adults MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 98 | EUCTR2014-002321-35-FR (EUCTR) | 21/02/2018 | A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | Seizures associated with Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: perampanel Other descriptive name: PERAMPANEL Trade Name: Fycompa Product Name: perampanel Product Code: E2007 INN or Proposed INN: Perampanel Other descriptive name: PERAMPANEL | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | |||
| 99 | EUCTR2021-002482-17-BE (EUCTR) | 20/12/2021 | Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes | A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). | Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT | Takeda Development Center Americas, Inc | NULL | NA | Female: yes Male: yes | 376 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan | |||
| 100 | EUCTR2019-001331-31-PL (EUCTR) | 20/04/2020 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet syndrome or Lennox-Gastaut syndrome MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 101 | EUCTR2016-004952-30-Outside-EU/EEA (EUCTR) | 13/02/2017 | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | Lennox-Gastaut Syndrome (LSG);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Product Name: rufinamide Product Code: E2080 INN or Proposed INN: RUFINAMIDE | Eisai Co, Ltd. | NULL | NA | Female: yes Male: yes | 58 | Phase 3 | Japan |