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Clinical trials for Stiripentol

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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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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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    8 result(s) found for: Stiripentol. Displaying page 1 of 1.
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001005-43 Sponsor Protocol Number: STP225 Start Date*: Information not available in EudraCT
    Sponsor Name:Biocodex
    Full Title: Etude de l’intérêt de l’association du stiripentol (Diacomit®) et de la carbamazépine dans le traitement des patients atteints d’épilepsies focales pharmacorésistantes.
    Medical condition: L’association carbamazépine/stiripentol est utilisée dans la pratique quotidienne à l’hôpital Necker chez les enfants atteints d’épilepsies focales. Il est donc pertinent d’étudier l’impact de cett...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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
    EudraCT Number: 2013-002195-40 Sponsor Protocol Number: 13/0656 Start Date*: 2014-09-02
    Sponsor Name:University College London
    Full Title: A randomised controlled trial of the ketogenic diet in the treatment of epilepsy in children under the age of two years
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    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: 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: 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: 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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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