140. ドラベ症候群 Dorabe syndrome Clinical trials / Disease details
臨床試験数 : 104 / 薬物数 : 61 - (DrugBank : 14) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 63
| 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 | EUCTR2021-002480-22-BE (EUCTR) | 20/12/2021 | 11/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 4 | EUCTR2021-002480-22-HU (EUCTR) | 15/11/2021 | 15/11/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 5 | EUCTR2021-002480-22-NL (EUCTR) | 04/11/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan | ||
| 6 | JPRN-jRCT2051210074 | 28/10/2021 | 04/09/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet 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. The total duration of the treatment will be up to 16 weeks (Treatment Period). The 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. The total duration of the treatment will be up to 16 weeks (Treatment Period). The 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 | <= 21age old | Both | 142 | Phase 3 | Ukraine;United States;Russia;Serbia;Belgium;France;Greece;Hungary;Italy;Latvia;Poland;Netherlands;United Kingdom;Australia;Canada;China;Spain;Japan |
| 7 | NCT04940624 (ClinicalTrials.gov) | October 28, 2021 | 16/6/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) | Drug: Soticlestat;Drug: Placebo | Takeda | NULL | Recruiting | 2 Years | 21 Years | All | 142 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 8 | EUCTR2021-002480-22-ES (EUCTR) | 15/10/2021 | 30/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 9 | EUCTR2021-002480-22-PL (EUCTR) | 13/10/2021 | 15/09/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) - Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 10 | EUCTR2021-002480-22-IT (EUCTR) | 12/10/2021 | 27/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) - Skyline | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 11 | EUCTR2021-002480-22-GR (EUCTR) | 22/09/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | 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 | NCT04740476 (ClinicalTrials.gov) | January 21, 2021 | 2/2/2021 | An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome | An Open-Label Extension Study for Patients With Dravet Syndrome Who Previously Participated in Studies of STK-001 | Dravet Syndrome | Drug: STK-001 | Stoke Therapeutics, Inc | NULL | Enrolling by invitation | 30 Months | N/A | All | 48 | Phase 2 | United States |
| 14 | NCT04572243 (ClinicalTrials.gov) | September 23, 2020 | 30/9/2020 | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome | Epilepsies, Myoclonic | Drug: Placebo;Drug: Lorcaserin | Eisai Inc. | NULL | Recruiting | 2 Years | N/A | All | 58 | Phase 3 | United States;Canada |
| 15 | NCT04462770 (ClinicalTrials.gov) | September 15, 2020 | 6/7/2020 | EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome | A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Patients With Dravet Syndrome | Dravet Syndrome | Drug: EPX-100 (Clemizole HCl);Drug: Placebo | Epygenix | NULL | Recruiting | 2 Years | 80 Years | All | 60 | Phase 2 | United States;Canada |
| 16 | NCT04457687 (ClinicalTrials.gov) | September 8, 2020 | 30/6/2020 | Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies | Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies | Epilepsies, Myoclonic;Drug Resistant Epilepsy | Drug: Lorcaserin | Eisai Inc. | NULL | Available | 2 Years | N/A | All | NULL | ||
| 17 | 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 | ||
| 18 | NCT04442295 (ClinicalTrials.gov) | June 3, 2020 | 8/6/2020 | An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome | An Open-Label Study to Investigate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Antisense Oligonucleotide STK-001 in Children and Adolescents With Dravet Syndrome | Dravet Syndrome | Drug: STK-001 - Single Ascending Doses;Drug: STK-001 - Multiple Ascending Doses | Stoke Therapeutics, Inc | NULL | Recruiting | 2 Years | 18 Years | All | 70 | Phase 1/Phase 2 | United States |
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 | ||
| 22 | JPRN-jRCTs041190116 | 17/02/2020 | 17/02/2020 | 3D gait analysis and L-DOPA in Dravet syndrome. | 3D gait analysis and effectiveness of L-DOPA on pathological gait in Dravet syndrome. | Dravet syndrome(severe myoclonic epilepsy in infant) Dravet syndrome, severe myoclonic epilepsy in infant;D004831 | Arm A:0) 3D gait analysis and RS-fMRI before medication 1) levodopa/carbidopa(5mg/kg/day or 300mg/day(more than 60kg)) given orally during 4-6weeks 2) second 3D gait analysis and RS-fMRI 3) reduce and stop medication durring 4weeks, no medication during 4-6weeks 4)third 3D gait analysis Arm B:0) 3D gait analysis and RS-fMRI before medication 1) 4-6weeks with no medication 2) second 3D gait analysis 3) levodopa/carbidopa given orally during 4-6weeks 4)third 3D gait analysis and second RS-fMRI | Natsume Jun | NULL | Recruiting | >= 6age old | Not applicable | Both | 20 | Phase 4 | Japan |
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | JPRN-jRCT2041200095 | 18/11/2019 | 29/01/2021 | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet syndrome | ZX008 (Fenfluramine Hydrochloride) Oral Solution Initial dose: 0.2mg/kg, Max daily dose: 30mg | YAMAMOTO Hideichiro | NULL | Not Recruiting | >= 2age old | <= 35age old | Both | 390 | Phase 3 | Australia;Belgium;Canda;Denmark;France;Germany;Italy;Korea;Netherland;Norway;Spain;Sweeded;UK;US;Japan |
| 28 | 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 | ||
| 29 | NCT04069689 (ClinicalTrials.gov) | August 29, 2019 | 22/8/2019 | Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects. | A Phase I, Placebo-Controlled, Double-Blind, 2-Period Study to Assess Safety and Pharmacokinetics of Escalating Single and Multiple Oral Doses of EPX-100 in Fasting Healthy Subjects and Following a High-Fat Meal | Dravet Syndrome | Drug: EPX-100 (Clemizole Hydrochloride);Drug: Placebos | Epygenix | NULL | Completed | 18 Years | 50 Years | All | 24 | Phase 1 | United States |
| 30 | 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 | ||
| 31 | JPRN-JapicCTI-194872 | 31/7/2019 | 19/07/2019 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet syndrome | Intervention name : ZX008 INN of the intervention : fenfluramine hydrochloride Dosage And administration of the intervention : Oral administration Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | Zogenix International Limited | NULL | complete | 2 | 18 | BOTH | 12 | Phase 3 | Japan, Europe, Australia |
| 32 | EUCTR2018-002484-25-PT (EUCTR) | 29/04/2019 | 19/11/2018 | A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut) | 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 (ELEKTRA) | Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TAK-935 INN or Proposed INN: None at this time Product Code: TAK-935 INN or Proposed INN: None at this time | Takeda Development Center Americas, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Portugal;Canada;Spain;Poland;Australia;Israel;China | ||
| 33 | 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 |
| 34 | EUCTR2018-002484-25-PL (EUCTR) | 14/03/2019 | 11/12/2018 | A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut) | 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 (ELEKTRA) | Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TAK-935 INN or Proposed INN: None at this time Product Code: TAK-935 INN or Proposed INN: None at this time | Takeda Development Center Americas, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Portugal;Canada;Spain;Poland;Australia;Israel;China | ||
| 35 | NCT03780127 (ClinicalTrials.gov) | November 30, 2018 | 14/12/2018 | ZX008 Expanded Access Protocol | ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan | Dravet Syndrome | Drug: Fenfluramine Hydrochloride | Zogenix, Inc. | NULL | Approved for marketing | 2 Years | N/A | All | NULL | ||
| 36 | 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | NCT04437004 (ClinicalTrials.gov) | January 3, 2018 | 21/2/2020 | Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) | Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) | Dravet Syndrome | Drug: Fenfluramine | University of California, Los Angeles | NULL | Available | 2 Years | N/A | All | United States | ||
| 41 | NCT02318563 (ClinicalTrials.gov) | December 30, 2017 | 12/12/2014 | Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet 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 Dravet Syndrome | Dravet Syndrome | Drug: Cannabidiol Oral Solution;Drug: Placebo Solution | INSYS Therapeutics Inc | NULL | Withdrawn | 1 Year | 30 Years | All | 0 | Phase 3 | NULL |
| 42 | NCT03299842 (ClinicalTrials.gov) | August 23, 2017 | 10/9/2017 | A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome | An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Enrolling by invitation | N/A | N/A | All | 20 | Phase 3 | United States |
| 43 | EUCTR2016-000474-38-ES (EUCTR) | 31/05/2017 | 07/04/2017 | A Multicenter, Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 Oral Solution When Added to Standard of Care, Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to standar treatment in Children and Young Adults with Dravet Syndrome | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 44 | EUCTR2016-000474-38-GB (EUCTR) | 06/04/2017 | 17/01/2017 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 45 | EUCTR2016-002804-14-IT (EUCTR) | 04/04/2017 | 07/09/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden | ||
| 46 | EUCTR2016-002804-14-NL (EUCTR) | 04/04/2017 | 09/11/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 47 | EUCTR2016-000474-38-DE (EUCTR) | 31/03/2017 | 27/12/2016 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom | ||
| 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 | EUCTR2016-002804-14-ES (EUCTR) | 23/12/2016 | 26/10/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 310 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Sweden | ||
| 50 | EUCTR2016-002804-14-DK (EUCTR) | 15/11/2016 | 28/09/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Seizures associated with Dravet syndrome 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 (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;United States;Canada;Spain;Belgium;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 51 | EUCTR2016-002804-14-DE (EUCTR) | 11/11/2016 | 29/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Seizures associated with Dravet's syndrome 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 (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 52 | EUCTR2015-004167-37-SE (EUCTR) | 09/11/2016 | 08/06/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Adolescents with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 53 | EUCTR2016-002804-14-GB (EUCTR) | 08/11/2016 | 11/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Seizures associated with Dravet syndrome 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 (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 54 | NCT02758626 (ClinicalTrials.gov) | November 2016 | 4/4/2016 | Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome | A Phase 2 Randomized, Double-Masked Placebo-Controlled Crossover Safety and Tolerability Study of Ataluren for Drug Resistant Epilepsy in Patients With Nonsense Mutation CDKL5 or Dravet Syndrome | Epilepsy | Drug: ataluren;Drug: Placebo | NYU Langone Health | PTC Therapeutics | Completed | 2 Years | 12 Years | All | 16 | Phase 2 | United States |
| 55 | EUCTR2016-002804-14-BE (EUCTR) | 26/09/2016 | 17/08/2016 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Seizures associated with Dravet's syndrome 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 (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 56 | EUCTR2016-000474-38-NL (EUCTR) | 13/09/2016 | 30/03/2016 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Netherlands;United Kingdom | ||
| 57 | NCT02926898 (ClinicalTrials.gov) | September 2016 | 10/8/2016 | A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children =2 Years Old and Young Adults With Dravet Syndrome | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care , Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Completed | 2 Years | 18 Years | All | 105 | Phase 3 | United States;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 58 | EUCTR2015-004167-37-DE (EUCTR) | 15/07/2016 | 10/02/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 59 | NCT02826863 (ClinicalTrials.gov) | July 15, 2016 | 13/6/2016 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Recruiting | 2 Years | 18 Years | All | 130 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden |
| 60 | EUCTR2015-004167-37-DK (EUCTR) | 14/06/2016 | 18/03/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome 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 Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | France;Spain;Belgium;Australia;Denmark;Norway;Germany;United Kingdom;Switzerland;Japan;Italy;Sweden | ||
| 61 | NCT02823145 (ClinicalTrials.gov) | June 2016 | 13/6/2016 | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 35 Years | All | 373 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Norway;Sweden |
| 62 | EUCTR2015-004167-37-BE (EUCTR) | 30/05/2016 | 11/02/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden;Korea, Republic of | ||
| 63 | EUCTR2015-004167-37-IT (EUCTR) | 17/05/2016 | 15/11/2018 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome - Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and yo | Dravet syndrome 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 Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato | ZOGENIX INTERNATIONAL LTD | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | France;Spain;Belgium;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Sweden;Korea, Republic of | ||
| 64 | EUCTR2015-004167-37-GB (EUCTR) | 17/05/2016 | 09/02/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Sweden;United Kingdom;Switzerland;Italy;Germany;Norway;Australia | ||
| 65 | EUCTR2015-004167-37-ES (EUCTR) | 12/05/2016 | 10/06/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | ||
| 66 | NCT02682927 (ClinicalTrials.gov) | January 2016 | 5/2/2016 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome;Seizure Disorder | Drug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 18 Years | All | 130 | Phase 3 | United States;Canada |
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 |
| 71 | 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 | ||
| 72 | NCT02224703 (ClinicalTrials.gov) | April 13, 2015 | 21/8/2014 | GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. | Epilepsy;Dravet Syndrome | Drug: GWP42003-P;Drug: Placebo Control | GW Research Ltd | NULL | Completed | 2 Years | 18 Years | All | 199 | Phase 3 | United States;Australia;Israel;Netherlands;Poland;Spain |
| 73 | EUCTR2014-002939-34-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome MedDRA version: 17.1;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 | 120 | Phase 3 | United States;Poland;Spain;Israel;Netherlands;United Kingdom | ||
| 74 | NCT02091375 (ClinicalTrials.gov) | March 30, 2015 | 17/3/2014 | Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1) | A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | Epilepsy;Dravet Syndrome | Drug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo control | GW Research Ltd | NULL | Completed | 2 Years | 18 Years | All | 120 | Phase 3 | United States;France;Poland;United Kingdom |
| 75 | EUCTR2014-000995-24-PL (EUCTR) | 09/03/2015 | 31/10/2014 | A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet Syndrome MedDRA version: 18.1;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 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 | 125 | France;United States;Poland;United Kingdom | |||
| 76 | EUCTR2014-002939-34-NL (EUCTR) | 04/03/2015 | 16/03/2015 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome 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 | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 77 | NCT02174094 (ClinicalTrials.gov) | March 2015 | 2/6/2014 | Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Dravet Syndrome | Drug: Clobazam;Drug: Placebo | H. Lundbeck A/S | NULL | Withdrawn | 1 Year | 16 Years | Both | 0 | Phase 3 | United States;Mexico |
| 78 | NCT02187809 (ClinicalTrials.gov) | March 2015 | 9/7/2014 | Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Dravet Syndrome | Drug: Clobazam | H. Lundbeck A/S | NULL | Terminated | 1 Year | 16 Years | All | 3 | Phase 3 | United States;Mexico |
| 79 | 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 | ||
| 80 | EUCTR2014-002939-34-GB (EUCTR) | 29/12/2014 | 24/09/2014 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome MedDRA version: 17.0;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 | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Spain;Israel;Netherlands;United Kingdom | ||
| 81 | NCT02091206 (ClinicalTrials.gov) | October 22, 2014 | 17/3/2014 | A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) | A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | Epilepsy;Dravet Syndrome | Drug: GWP42003-P 5 mg/kg/day Dose;Drug: Placebo control;Drug: GWP42003-P 10 mg/kg/day Dose;Drug: GWP42003-P 20 mg/kg/day Dose | GW Research Ltd | NULL | Completed | 4 Years | 10 Years | All | 34 | Phase 2 | United States;United Kingdom |
| 82 | EUCTR2014-000995-24-GB (EUCTR) | 09/09/2014 | 04/07/2014 | A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet Syndrome 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 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 | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Poland;United Kingdom | ||
| 83 | NCT02239276 (ClinicalTrials.gov) | September 2014 | 10/9/2014 | Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies | Expanded Access Use of Stiripentol in Participants With Dravet Syndrome or Epileptic Encephalopathies Associated With Sodium Channel Mutations | Dravet Syndrome;Epileptic Encephalopathies Associated With SCN1A Mutations | Drug: Stiripentol | Cook Children's Health Care System | NULL | No longer available | 6 Months | 18 Years | All | United States | ||
| 84 | NCT01983722 (ClinicalTrials.gov) | October 2013 | 7/11/2013 | Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome | Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome | Dravet Syndrome | Drug: Stiripentol | Children's Hospital Medical Center, Cincinnati | NULL | Approved for marketing | 6 Months | N/A | All | United States | ||
| 85 | NCT01835314 (ClinicalTrials.gov) | May 2013 | 15/4/2013 | Compassionate Use of Stiripentol in Dravet Syndrome | Compassionate Use of Stiripentol in Dravet Syndrome | Dravet Syndrome | Drug: Stiripentol | University of Colorado, Denver | NULL | No longer available | 1 Year | 21 Years | All | United States | ||
| 86 | JPRN-JapicCTI-205180 | 29/11/2012 | 25/02/2020 | Post-marketing surveillance of DIACOMITCapsule, Powder for Oral Suspension | Post-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg) | Dravet Syndrome | Intervention name : DIACOMIT (Stiripentol) INN of the intervention : stiripentol Dosage And administration of the intervention : Usually, for patients aged 1 year or older, 50 mg/kg of stiripentol per day is orally administered in divided doses two to three times a day during or immediately after a meal. Dosing starts at 20 mg/kg daily and is increased by 10 mg/kg at intervals of at least one week. However, for patients weighing 50 kg or more, start taking 1000 mg of stiripentol daily, and increase the dosage by 500 mg at intervals of one week or more. The maximum daily dose shall not exceed 50 mg/kg or 2500 mg, whichever is lower. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Meiji Seika Pharma Co., Ltd. | NULL | recruiting | BOTH | 300 | NA | Japan | ||
| 87 | NCT01607073 (ClinicalTrials.gov) | April 2012 | 24/5/2012 | Verapamil as Therapy for Children and Young Adults With Dravet Syndrome | Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: Verapamil | Gillette Children's Specialty Healthcare | Mayo Clinic;Ann & Robert H Lurie Children's Hospital of Chicago;Dartmouth-Hitchcock Medical Center | Completed | 2 Years | 25 Years | All | 2 | Phase 2 | United States |
| 88 | NCT01533506 (ClinicalTrials.gov) | February 2012 | 9/2/2012 | Stiripentol in Dravet Syndrome | Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome | Dravet Syndrome | Drug: stiripentol | Mayo Clinic | NULL | No longer available | 11 Years | N/A | Female | Phase 4 | United States | |
| 89 | JPRN-JapicCTI-101116 | 01/4/2010 | 28/04/2010 | Open Phase III Study of ME2080 in Patients with Dravet Syndrome | Open Phase III Study of ME2080 in Patients with Dravet Syndrome | Dravet Syndrome | Intervention name : ME2080 (stiripentol) Dosage And administration of the intervention : 50mg/kg/day administered twice or 3 times a day (maximum 2500mg/day) | Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.) | NULL | 1 | 30 | BOTH | 25 | Phase 3 | NULL | |
| 90 | JPRN-JMA-IIA00014 | 01/10/2007 | 06/11/2007 | Use of the antiepileptic drug stiripentol for the treatment of severe myoclonic epilepsy in infancy (SMEI) | Clinical evaluation of stiripentol in Dravet syndrome | Dravet syndrome (severe myoclonic epilepsy in infancy: SMEI) | Intervention type:DRUG. Intervention1:Stiripentol, Dose form:FINE GRANULES, Route of administration:ORAL, intended dose regimen:Stiripentol will be started at 50 mg/kg (or 1000 mg for patients weighing 20 kg or more) and will be titrated up to 100 mg/kg (maximum of 4.0 g).. | Yushi InoueNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders | Shunya IkedaDepartment of Pharmaceutical Sciences, International University of Health and WelfareYoko OhtsukaOkayama University, Graduate School of Medicine, Dentistry and Pharmaceutical SciencesHirokazu OguniDepartment of Pediatrics, Tokyo Women's Medical UniversityYukitoshi TakahashiNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological DisordersJun TohyamaNational Hospital Organization Nishi-Niigata Chuo National HospitalHiroshi BabaNational Hospital Organization Nagasaki Medical CenterKatsuyuki FukushimaNational Hospital Organization Yakumo Hospital | Completed | >=1 YEARS | BOTH | 10 | NOT APPLICABLE | Japan | |
| 91 | EUCTR2007-001784-30-FR (EUCTR) | 19/07/2007 | 01/06/2007 | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Antiepileptic | Trade Name: DIACOMIT Product Name: DIACOMIT Trade Name: DIACOMIT Product Name: DIACOMIT | BIOCODEX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 92 | EUCTR2007-003702-95-IT (EUCTR) | 03/07/2007 | 07/09/2007 | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND | Dravet Syndrome Level: PTClassification code 10054859 | Trade Name: stiripentolo Trade Name: TOPAMAX INN or Proposed INN: Topiramate Trade Name: FRISIUM*30CPS 10MG INN or Proposed INN: Clobazam | ISTITUTO C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Italy | |||
| 93 | EUCTR2007-002198-30-IT (EUCTR) | 03/07/2007 | 17/01/2012 | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY | Dravet Syndrome MedDRA version: 14.1;Level: PT;Classification code 10054859;Term: Myoclonic epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: stiripentolo INN or Proposed INN: Other antiepileptics Trade Name: TOPAMAX INN or Proposed INN: Topiramate Trade Name: FRISIUM*30CPS 10MG INN or Proposed INN: Clobazam | Inserm-ISP Pole Recherches cliniques et thérapeutiques | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
| 94 | 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 | |||
| 95 | EUCTR2015-004167-37-NO (EUCTR) | 07/03/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Germany;Norway;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | |||
| 96 | EUCTR2021-002480-22-Outside-EU/EEA (EUCTR) | 22/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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;France;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Spain;United Kingdom | ||||
| 97 | EUCTR2015-004167-37-FR (EUCTR) | 27/10/2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Product Name: Fenfluramine hydrochloride Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden | |||
| 98 | EUCTR2011-004114-42-BE (EUCTR) | 06/04/2021 | Fenfluramine as anti-epilepticum in a difficult to treat epilepsy syndrome. | Fenfluramine as anti-epilepticum in Dravet syndrome. | Fenfluramine is an amphetamine which was in the past used as anorexigan. Their are a few publications of effectivness of this medication in epilepsy.We want to investigate was is the exact place of fenfluramine in the treatment of a therapy resitant epilepsy named Dravet syndrome. MedDRA version: 21.0;Level: PT;Classification code 10015037;Term: Epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fenfluramine INN or Proposed INN: FENFLURAMINE | University Hospital Antwerp | NULL | NA | Female: yes Male: yes | 50 | Phase 3 | Belgium | |||
| 99 | EUCTR2014-002939-34-PL (EUCTR) | 25/01/2016 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome 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 | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | |||
| 100 | EUCTR2021-002480-22-LV (EUCTR) | 02/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 101 | EUCTR2016-002804-14-FR (EUCTR) | 12/01/2017 | Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride (red) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (red) Product Name: Fenfluramine hydrochloride (colorless) Product Code: ZX008 INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE Other descriptive name: FENFLURAMINE HYDROCHLORIDE (colorless) | Zogenix International Limited | NULL | NA | Female: yes Male: yes | 310 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden | |||
| 102 | 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 | |||
| 103 | EUCTR2021-002480-22-FR (EUCTR) | 29/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) 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: 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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 104 | 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 |