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"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04457687
(ClinicalTrials.gov)
November 9, 202030/6/2020Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory EpilepsiesExtended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory EpilepsiesEpilepsies, Myoclonic;Drug Resistant EpilepsyDrug: LorcaserinEisai Inc.NULLAvailable2 YearsN/AAllNULL
2NCT04572243
(ClinicalTrials.gov)
September 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
3NCT04462770
(ClinicalTrials.gov)
September 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
4EUCTR2019-001331-31-SE
(EUCTR)
17/06/202008/01/2020A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
5NCT04442295
(ClinicalTrials.gov)
June 3, 20208/6/2020An Open-Label Study to Investigate the Safety of Single Ascending Doses in Children and Adolescents With Dravet SyndromeAn Open-Label Study to Investigate the Safety and Pharmacokinetics of Single Ascending Doses of Antisense Oligonucleotide STK-001 in Children and Adolescents With Dravet SyndromeDravet SyndromeDrug: STK-001Stoke Therapeutics, IncNULLRecruiting2 Years18 YearsAll48Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-001331-31-DE
(EUCTR)
07/04/202013/11/2019A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
7NCT04611438
(ClinicalTrials.gov)
March 30, 202016/9/2019Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut SyndromeA Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: CannabidiolYonsei UniversityNULLRecruiting2 Years18 YearsAll107Phase 3Korea, Republic of
8EUCTR2019-001331-31-NL
(EUCTR)
12/03/202004/02/2020A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden
9JPRN-jRCTs041190116
17/02/202017/02/20203D 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 JunNULLRecruiting>= 6age oldNot applicableBoth20Phase 4Japan
10EUCTR2019-001331-31-DK
(EUCTR)
17/01/202026/09/2019A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-001331-31-FR
(EUCTR)
13/12/201916/10/2019A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden
12EUCTR2019-001331-31-ES
(EUCTR)
10/12/201906/11/2019A 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 SyndromeAn 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]
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
13EUCTR2019-001331-31-GB
(EUCTR)
07/11/201929/08/2019A 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 SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
14NCT04069689
(ClinicalTrials.gov)
August 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
15JPRN-JapicCTI-194872
31/7/201919/07/2019A 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 LimitedNULLcomplete218BOTH12Phase 3Japan, Europe, Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-002484-25-PT
(EUCTR)
29/04/201919/11/2018A 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
17NCT03936777
(ClinicalTrials.gov)
April 22, 201912/4/2019A 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 SyndromeAn 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 SyndromeDravet Syndrome;Lennox Gastaut Syndrome;Epileptic EncephalopathyDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix, Inc.Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Enrolling by invitation2 YearsN/AAll650Phase 3United States;Australia;Belgium;Canada;Denmark;Spain;United Kingdom
18EUCTR2018-002484-25-PL
(EUCTR)
14/03/201911/12/2018A 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
126Phase 2Portugal;United States;Canada;Spain;Poland;Australia;Israel;China
19NCT03780127
(ClinicalTrials.gov)
February 1, 201914/12/2018ZX008 Expanded Access ProtocolZX008 Expanded Access Protocol - Dravet Syndrome Treatment PlanDravet SyndromeDrug: Fenfluramine HydrochlorideZogenix, Inc.NULLAvailable2 YearsN/AAllNULL
20NCT03650452
(ClinicalTrials.gov)
August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03635073
(ClinicalTrials.gov)
July 19, 20186/8/2018A 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 Rare EpilepsyA 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 Rare EpilepsyEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency DisorderDrug: TAK-935TakedaOvid Therapeutics Inc.Recruiting2 Years65 YearsAll176Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
22NCT03254680
(ClinicalTrials.gov)
March 201815/8/2017Turmeric as Treatment in EpilepsyTurmeric as Treatment in EpilepsyEpilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal SeizuresDietary Supplement: TurmericNYU Langone HealthNULLWithdrawn1 Year70 YearsAll0N/AUnited States
23NCT03467113
(ClinicalTrials.gov)
January 19, 201830/1/2018A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBDAn 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 SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 and 0.8 mg/kg/dayZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLActive, not recruiting2 Years18 YearsAll25Phase 1;Phase 2United States
24NCT04437004
(ClinicalTrials.gov)
January 3, 201821/2/2020Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)Dravet SyndromeDrug: FenfluramineUniversity of California, Los AngelesNULLAvailable2 YearsN/AAllUnited States
25NCT02318563
(ClinicalTrials.gov)
December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03299842
(ClinicalTrials.gov)
August 23, 201710/9/2017A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet SyndromeAn 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 TrialDravet SyndromeDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLEnrolling by invitationN/AN/AAll20Phase 3United States
27EUCTR2016-000474-38-ES
(EUCTR)
31/05/201707/04/2017A 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: 19.1;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 LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;United States;Canada;Spain;Netherlands;Germany;United Kingdom
28EUCTR2016-000474-38-GB
(EUCTR)
06/04/201717/01/2017A 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
110Phase 3France;United States;Canada;Spain;Netherlands;Germany;United Kingdom
29EUCTR2016-002804-14-NL
(EUCTR)
04/04/201709/11/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
310Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden
30EUCTR2016-002804-14-IT
(EUCTR)
04/04/201707/09/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
310Phase 3United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-000474-38-DE
(EUCTR)
31/03/201727/12/2016A 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
110Phase 3France;United States;Canada;Spain;Netherlands;Germany;United Kingdom
32NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1;Phase 2United States
33EUCTR2016-002804-14-ES
(EUCTR)
23/12/201626/10/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
310Phase 3France;United States;Canada;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Sweden
34EUCTR2016-002804-14-DK
(EUCTR)
15/11/201628/09/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3France;United States;Canada;Spain;Belgium;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy
35EUCTR2016-002804-14-DE
(EUCTR)
11/11/201629/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2015-004167-37-SE
(EUCTR)
09/11/201608/06/2016Study 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: 19.1;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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden
37EUCTR2016-002804-14-GB
(EUCTR)
08/11/201611/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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]
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
390Phase 3France;United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
38NCT02758626
(ClinicalTrials.gov)
November 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
39EUCTR2016-002804-14-BE
(EUCTR)
26/09/201617/08/2016Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
40EUCTR2016-000474-38-NL
(EUCTR)
13/09/201630/03/2016A 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: 18.1;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 LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Spain;Germany;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
41NCT02926898
(ClinicalTrials.gov)
September 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
42NCT02826863
(ClinicalTrials.gov)
July 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
43EUCTR2015-004167-37-DE
(EUCTR)
15/07/201610/02/2016Study 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: 20.0;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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Sweden
44EUCTR2015-004167-37-DK
(EUCTR)
14/06/201618/03/2016Study 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
275Phase 3France;Belgium;Spain;Australia;Denmark;Norway;Germany;Japan;Italy;United Kingdom;Switzerland;Sweden
45NCT02823145
(ClinicalTrials.gov)
June 201613/6/2016An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet SyndromeAn 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 SyndromeDravet SyndromeDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLEnrolling by invitation2 Years35 YearsAll340Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2015-004167-37-BE
(EUCTR)
30/05/201611/02/2016Study 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
260Phase 3France;Spain;Belgium;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
47EUCTR2015-004167-37-IT
(EUCTR)
17/05/201615/11/2018Study 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: 20.0;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 LTDNULLNot RecruitingFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Korea, Republic of;Sweden
48EUCTR2015-004167-37-GB
(EUCTR)
17/05/201609/02/2016Study 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: 19.0;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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;Switzerland;United Kingdom;Sweden
49EUCTR2015-004167-37-ES
(EUCTR)
12/05/201610/06/2016Study 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
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
50NCT02682927
(ClinicalTrials.gov)
January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
52EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
53EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
54NCT02224573
(ClinicalTrials.gov)
June 201521/8/2014GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn 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 SyndromeDrug: GWP42003-PGW Research LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
55EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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]
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
430Phase 3France;United 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
56NCT02224703
(ClinicalTrials.gov)
April 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
57EUCTR2014-002939-34-ES
(EUCTR)
08/04/201516/12/2014A 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: 17.1;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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
58NCT02091375
(ClinicalTrials.gov)
March 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
59EUCTR2014-000995-24-PL
(EUCTR)
09/03/201531/10/2014A 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: 18.1;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 LtdNULLNot RecruitingFemale: yes
Male: yes
125France;United States;Poland;United Kingdom
60EUCTR2014-002939-34-NL
(EUCTR)
04/03/201516/03/2015A 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Poland;Spain;Australia;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
61NCT02187809
(ClinicalTrials.gov)
March 20159/7/2014Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeMulti-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 SyndromeDravet SyndromeDrug: ClobazamH. Lundbeck A/SNULLTerminated1 Year16 YearsAll3Phase 3United States;Mexico
62NCT02174094
(ClinicalTrials.gov)
March 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
63EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
64EUCTR2014-002939-34-GB
(EUCTR)
29/12/201424/09/2014A 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
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
65NCT02091206
(ClinicalTrials.gov)
October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2014-000995-24-GB
(EUCTR)
09/09/201404/07/2014A 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
125Phase 2;Phase 3France;United States;Poland;United Kingdom
67NCT02239276
(ClinicalTrials.gov)
September 201410/9/2014Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic EncephalopathiesExpanded Access Use of Stiripentol in Participants With Dravet Syndrome or Epileptic Encephalopathies Associated With Sodium Channel MutationsDravet Syndrome;Epileptic Encephalopathies Associated With SCN1A MutationsDrug: StiripentolCook Children's Health Care SystemNULLNo longer available6 Months18 YearsAllUnited States
68NCT01983722
(ClinicalTrials.gov)
October 20137/11/2013Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet SyndromeTreatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet SyndromeDravet SyndromeDrug: StiripentolChildren's Hospital Medical Center, CincinnatiNULLApproved for marketing6 MonthsN/AAllUnited States
69NCT01835314
(ClinicalTrials.gov)
May 201315/4/2013Compassionate Use of Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Dravet SyndromeDravet SyndromeDrug: StiripentolUniversity of Colorado, DenverNULLNo longer available1 Year21 YearsAllUnited States
70JPRN-JapicCTI-205180
29/11/201225/02/2020Post-marketing surveillance of DIACOMITCapsule, Powder for Oral SuspensionPost-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg) Dravet SyndromeIntervention 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.NULLrecruitingBOTH300NAJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT01607073
(ClinicalTrials.gov)
April 201224/5/2012Verapamil as Therapy for Children and Young Adults With Dravet SyndromeVerapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet SyndromeDravet SyndromeDrug: VerapamilBeverly S. Wical, M.D.Dartmouth-Hitchcock Medical Center;Mayo Clinic;Ann & Robert H Lurie Children's Hospital of ChicagoCompleted2 Years25 YearsBoth2Phase 2United States
72NCT01533506
(ClinicalTrials.gov)
February 20129/2/2012Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet SyndromeDravet SyndromeDrug: stiripentolMayo ClinicNULLNo longer available11 YearsN/AFemalePhase 4United States
73JPRN-JapicCTI-101116
01/4/201028/04/2010Open Phase III Study of ME2080 in Patients with Dravet SyndromeOpen Phase III Study of ME2080 in Patients with Dravet Syndrome Dravet SyndromeIntervention 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.)NULL130BOTH25Phase 3NULL
74JPRN-JMA-IIA00014
01/10/200706/11/2007Use 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 DisordersShunya 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 HospitalCompleted>=1 YEARSBOTH10NOT APPLICABLEJapan
75EUCTR2007-001784-30-FR
(EUCTR)
19/07/200701/06/2007Population 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. AntiepilepticTrade Name: DIACOMIT
Product Name: DIACOMIT
Trade Name: DIACOMIT
Product Name: DIACOMIT
BIOCODEXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2007-002198-30-IT
(EUCTR)
03/07/200717/01/2012A 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 STUDYA 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 thérapeutiquesNULLNot RecruitingFemale: yes
Male: yes
90Italy
77EUCTR2007-003702-95-IT
(EUCTR)
03/07/200707/09/2007A 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 - NDA 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. MONDINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Italy
78EUCTR2014-002939-34-PL
(EUCTR)
25/01/2016A 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
79EUCTR2016-002804-14-FR
(EUCTR)
12/01/2017Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeAn 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 LimitedNULLNAFemale: yes
Male: yes
310Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Sweden
80EUCTR2015-004167-37-FR
(EUCTR)
27/10/2016Study 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: 19.0;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 LimitedNULLNAFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;United Kingdom;Switzerland;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
81EUCTR2019-001331-31-PL
(EUCTR)
20/04/2020A 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 SyndromeAn 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 LimitedNULLNAFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden
82EUCTR2015-004167-37-NO
(EUCTR)
07/03/2016Study 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: 18.1;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 LimitedNULLNAFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Germany;Norway;Italy;United Kingdom;Switzerland;Korea, Republic of;Sweden
83EUCTR2019-001331-31-BE
(EUCTR)
26/09/2019A 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 SyndromeAn 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 LimitedNULLNAFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden