140. ドラベ症候群 [臨床試験数:83,薬物数:54(DrugBank:13),標的遺伝子数:48,標的パスウェイ数:62

Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
35 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04572243September 23, 202030/9/2020A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet SyndromeEpilepsies, MyoclonicDrug: Placebo;Drug: LorcaserinEisai Inc.NULLRecruiting2 YearsN/AAll58Phase 3United States
2NCT04462770September 20206/7/2020A Trial of EPX-100 (Clemizole Hydrochloride) as an Add-on Therapy in Children With Dravet SyndromeA 20-Week Multicenter, Randomized, Double-Blind, Placebo- Controlled, Proof of Concept Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children With Dravet SyndromeDravet SyndromeDrug: EPX-100 (Clemizole HCl);Drug: PlaceboEpygenixGreenLight Clinical PTY LTDRecruiting2 Years17 YearsAll24Phase 2United States
3NCT04069689August 29, 201922/8/2019Study 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 MealDravet SyndromeDrug: EPX-100 (Clemizole Hydrochloride);Drug: PlacebosEpygenixNULLCompleted18 Years50 YearsAll24Phase 1United States
4JPRN-JapicCTI-19487231/7/201919/07/2019A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeA 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 syndromeIntervention 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 LimitedNULLcomplete218BOTH12Japan, Europe, Australia
5EUCTR2018-002484-25-PT29/04/201919/11/2018A 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
Ovid Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 2United States;Portugal;Canada;Poland;Spain;Australia;Israel;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002484-25-PL14/03/201911/12/2018A 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 AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Ovid Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Canada;Spain;Poland;Australia;Israel;China
7NCT03650452August 8, 201827/8/2018A 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 EncephalopathiesA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Completed2 Years17 YearsAll141Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
8NCT02318563December 30, 201712/12/2014Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet SyndromeA 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 SyndromeDravet SyndromeDrug: Cannabidiol Oral Solution;Drug: Placebo SolutionINSYS Therapeutics IncNULLWithdrawn1 Year30 YearsAll0Phase 3NULL
9EUCTR2016-000474-38-ES31/05/201707/04/2017A 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 SyndromeA 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: 19.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;United States;Canada;Spain;Netherlands;Germany;United Kingdom
10EUCTR2016-000474-38-GB06/04/201717/01/2017A 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]
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-000474-38-DE31/03/201727/12/2016A 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]
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;United Kingdom
12EUCTR2015-004167-37-SE09/11/201608/06/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 19.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden
13NCT02758626November 20164/4/2016Ataluren for Nonsense Mutation in CDKL5 and Dravet SyndromeA 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 SyndromeEpilepsyDrug: ataluren;Drug: PlaceboNYU Langone HealthPTC TherapeuticsActive, not recruiting2 Years12 YearsAll16Phase 2United States
14EUCTR2016-000474-38-NL13/09/201630/03/2016A 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: 18.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Spain;Germany;Netherlands;United Kingdom
15NCT02926898September 201610/8/2016A 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 SyndromeA 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 SyndromeDravet SyndromeDrug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll105Phase 3United States;Canada;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02826863July 15, 201613/6/2016A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeA 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 SyndromeDravet SyndromeDrug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLRecruiting2 Years18 YearsAll130Phase 3Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden
17EUCTR2015-004167-37-DE15/07/201610/02/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden
18EUCTR2015-004167-37-DK14/06/201618/03/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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]
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
275 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Belgium;Spain;Australia;Denmark;Norway;Germany;Japan;Italy;United Kingdom;Switzerland;Sweden
19EUCTR2015-004167-37-BE30/05/201611/02/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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]
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Belgium;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
20EUCTR2015-004167-37-IT17/05/201615/11/2018Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LTDNULLNot RecruitingFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-004167-37-GB17/05/201609/02/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 19.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;Switzerland;United Kingdom;Sweden
22EUCTR2015-004167-37-ES12/05/201610/06/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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]
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
23NCT02682927January 20165/2/2016A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet SyndromeA 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 SyndromeDravet Syndrome;Seizure DisorderDrug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLActive, not recruiting2 Years18 YearsAll130Phase 3United States;Canada
24NCT02224703April 13, 201521/8/2014GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeA 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 SyndromeDrug: GWP42003-P;Drug: Placebo ControlGW Research LtdNULLCompleted2 Years18 YearsAll199Phase 3United States;Australia;Israel;Netherlands;Poland;Spain
25EUCTR2014-002939-34-ES08/04/201516/12/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 17.1Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02091375March 30, 201517/3/2014Antiepileptic 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 SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo controlGW Research LtdNULLCompleted2 Years18 YearsAll120Phase 3United States;France;Poland;United Kingdom
27EUCTR2014-000995-24-PL09/03/201531/10/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 18.1Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
125France;United States;Poland;United Kingdom
28EUCTR2014-002939-34-NL04/03/201516/03/2015A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
29NCT02174094March 20152/6/2014Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeMulti-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 SyndromeDravet SyndromeDrug: Clobazam;Drug: PlaceboH. Lundbeck A/SNULLWithdrawn1 Year16 YearsBoth0Phase 3United States;Mexico
30EUCTR2014-002939-34-GB29/12/201424/09/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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]
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Poland;Spain;Israel;Netherlands;United Kingdom
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
31NCT02091206October 22, 201417/3/2014A 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 SyndromeEpilepsy;Dravet SyndromeDrug: 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 DoseGW Research LtdNULLCompleted4 Years10 YearsAll34Phase 2United States;United Kingdom
32EUCTR2014-000995-24-GB09/09/201404/07/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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]
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Poland;United Kingdom
33EUCTR2014-002939-34-PL25/01/2016A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
34EUCTR2015-004167-37-FR27/10/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 19.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLNAFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
35EUCTR2015-004167-37-NO07/03/2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA 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: 18.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem 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 LimitedNULLNAFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Germany;Norway;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden