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Clinical trials for Dravet Syndrome

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    18 result(s) found for: Dravet Syndrome. Displaying page 1 of 1.
    EudraCT Number: 2019-001331-31 Sponsor Protocol Number: ZX008-1900 Start Date*: 2019-11-07
    Sponsor Name:Zogenix International Limited
    Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such a...
    Medical condition: Dravet syndrome or Lennox-Gastaut syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) DK (Completed) FR (Ongoing) ES (Ongoing) DE (Completed) SE (Completed) NL (Ongoing) PL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003425-30 Sponsor Protocol Number: EPX-100-001 Start Date*: 2022-07-27
    Sponsor Name:Epygenix Therapeutics, Inc.
    Full Title: A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole HCl) as Adjunctive Therapy in Patients with Dravet Syndrome (ARGUS trial)
    Medical condition: Dravet Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) HU (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002484-25 Sponsor Protocol Number: TAK-935-2002(OV935) Start Date*: 2019-04-29
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: 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 ...
    Medical condition: Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-001784-30 Sponsor Protocol Number: STIPOP - STP167 Start Date*: 2007-07-19
    Sponsor Name:BIOCODEX
    Full Title: Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.
    Medical condition: Antiepileptic
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000474-38 Sponsor Protocol Number: ZX008-1504 Start Date*: 2016-09-13
    Sponsor Name:Zogenix International Limited
    Full Title: 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), ...
    Medical condition: Dravet's syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-004167-37 Sponsor Protocol Number: ZX008-1502 Start Date*: 2016-05-17
    Sponsor Name:Zogenix International Limited
    Full Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and You...
    Medical condition: Dravet's syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) NO (Ongoing) DK (Completed) SE (Ongoing) ES (Completed) FR (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003702-95 Sponsor Protocol Number: EPICURE SUB05T02 Start Date*: 2007-07-03
    Sponsor Name:ISTITUTO C. MONDINO
    Full Title: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADE...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    10054859 PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002804-14 Sponsor Protocol Number: ZX008-1503 Start Date*: 2016-11-08
    Sponsor Name:Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc
    Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
    Medical condition: Seizures associated with Dravet syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) IT (Completed) DK (Completed) ES (Ongoing) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004114-42 Sponsor Protocol Number: Start Date*: 2011-08-26
    Sponsor Name:University Hospital Antwerp
    Full Title: Fenfluramine as anti-epilepticum in Dravet syndrome.
    Medical condition: Fenfluramine is an amphetamine which was in the past used as anorexigan. Their are a few publications of effectivness of this medication in epilepsy.We want to investigate was is the exact place of...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002198-30 Sponsor Protocol Number: EPICURESUB05T02 Start Date*: 2007-07-03
    Sponsor Name:Inserm-ISP Pole Recherches cliniques et thérapeutiques
    Full Title: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10054859 Myoclonic epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-001315-44 Sponsor Protocol Number: TAK-935-18-002(OV935) Start Date*: 2022-05-24
    Sponsor Name:Takeda Development Center America, Inc.
    Full Title: A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)
    Medical condition: Epileptic Encephalopathies: Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073682 Dravet syndrome LLT
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    22.1 10010331 - Congenital, familial and genetic disorders 10083005 CDKL5 deficiency disorder PT
    23.0 10010331 - Congenital, familial and genetic disorders 10083952 Dup15q syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002482-17 Sponsor Protocol Number: TAK-935-3003 Start Date*: 2022-05-09
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or ...
    Medical condition: Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) HU (Trial now transitioned) FR (Ongoing) GR (Trial now transitioned) IT (Ongoing) LV (Ongoing) PL (Trial now transitioned) Outside EU/EEA DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002485-39 Sponsor Protocol Number: TAK-935-18-001(OV935)Amendment1 Start Date*: 2019-06-14
    Sponsor Name:Ovid Therapeutics, Inc.
    Full Title: A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEP...
    Medical condition: developmental and epileptic encephalopathies
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned) PT (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-002480-22 Sponsor Protocol Number: TAK-935-3001 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adul...
    Medical condition: Dravet Syndrome (DS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Ongoing) FR (Ongoing) ES (Ongoing) LV (Ongoing) GR (Ongoing) NL (Ongoing) BE (Ongoing) PL (Ongoing) HU (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001834-27 Sponsor Protocol Number: GWEP1415 Start Date*: 2015-01-14
    Sponsor Name:GW Research Ltd
    Full Title: An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes
    Medical condition: Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) PL (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002939-34 Sponsor Protocol Number: GWEP1424 Start Date*: 2014-12-29
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
    Medical condition: Dravet syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000995-24 Sponsor Protocol Number: GWEP1332 Start Date*: 2014-09-09
    Sponsor Name:GW Research Ltd
    Full Title: 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 ...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002939-18 Sponsor Protocol Number: GWEP1447 Start Date*: 2016-04-29
    Sponsor Name:GW Research Ltd.
    Full Title: A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P ...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10073677 Severe myoclonic epilepsy of infancy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) NL (Completed) PL (Completed)
    Trial results: View results
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