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 | EUCTR2021-002480-22-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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 |
| 17 | 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 |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 |
| 23 | 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 | ||
| 24 | 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 |
| 25 | 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 | ||
| 26 | 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 |
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 |
| 33 | 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 |
| 34 | 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 | ||
| 35 | 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 |
| 36 | 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 | |||
| 37 | 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 | ||
| 38 | 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 |
| 39 | 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 | ||
| 40 | 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 |
| 41 | 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 | ||
| 42 | 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 | |||
| 43 | 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 | |||
| 44 | 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 | ||||
| 45 | 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 | |||
| 46 | 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 | |||
| 47 | 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 |