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Clinical trials for Status epilepticus

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • 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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    40 result(s) found for: Status epilepticus. Displaying page 2 of 2.
    EudraCT Number: 2004-004053-26 Sponsor Protocol Number: SEEG 0001 Start Date*: 2005-04-14
    Sponsor Name:Birthe Pedersen
    Full Title: An explorative use open-label, multi-center, randomized trial studying the safety and efficacy of levetiracetam (500 mg/day to 3000 mg/day) and valproate (600 mg/day to 3000 mg/day) as monotherapy ...
    Medical condition: Newly diagnosed epilepsy patients are over 65 years. In this age group more cases are symptomatic and it is apparently another disorder than epilepsy in adults. Epilepsy in the elderly is easier to...
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004827-30 Sponsor Protocol Number: RASLOW Start Date*: 2017-03-21
    Sponsor Name:AZIENDA OSPEDALIERA "BIANCHI-MELACRINO-MORELLI"
    Full Title: RAPID VERSUS SLOW WITHDRAWAL OF ANTIEPILEPTIC MONOTHERAPY IN TWO-YEAR SEIZURE-FREE ADULTS PATIENTS WITH EPILEPSY (RASLOW) STUDY: A PRAGMATIC MULTICENTRE, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY.
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10015046 Epilepsy, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000897-21 Sponsor Protocol Number: N01280 Start Date*: 2008-02-05
    Sponsor Name:UCB, Inc.
    Full Title: A multi-center, double-blind, historical control, randomized conversion to monotherapy study with Keppra XR for treatment of partial onset seizures
    Medical condition: partial onset seizures
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039911 Seizures (incl subtypes) HLGT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    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: 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: 2014-002940-42 Sponsor Protocol Number: GWEP1414 Start Date*: 2015-07-28
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut synd...
    Medical condition: Lennox-Gastaut syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-002941-23 Sponsor Protocol Number: GWEP1423 Start Date*: 2015-09-30
    Sponsor Name:GW Research Ltd.
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syn...
    Medical condition: Lennox-Gastaut syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005722-23 Sponsor Protocol Number: N01274 Start Date*: 2007-05-15
    Sponsor Name:UCB Pharma S.A.
    Full Title: Open-label, single-arm, multi-center, pharmacokinetic, safety and tolerability study of levetiracetam intravenous infusion in children (4 - 16 years old) with epilepsy.
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015037 Epilepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003517-13 Sponsor Protocol Number: N01275 Start Date*: 2007-12-11
    Sponsor Name:UCB Pharma S.A.
    Full Title: Open-label, single-arm, multi-center, pharmacokinetic, safety and tolerability study of levetiracetam intravenous infusion in children (1 month to 4 years old) with epilepsy.
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015037 Epilepsy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001559-35 Sponsor Protocol Number: SP848 Start Date*: 2012-06-11
    Sponsor Name:UCB BIOSCIENCES, Inc
    Full Title: AN OPEN-LABEL STUDY TO DETERMINE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM ORAL LACOSAMIDE (LCM) AS ADJUNCTIVE THERAPY IN CHILDREN WITH EPILEPSY
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) IT (Completed) Outside EU/EEA PL (Completed) FR (Completed)
    Trial results: View results
    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 (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    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: 2013-000531-27 Sponsor Protocol Number: NL43510 Start Date*: 2014-02-11
    Sponsor Name:University Medical Center Utrecht
    Full Title: Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
    Medical condition: Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) FI (Completed) ES (Prematurely Ended) BE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Ongoing) DK (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-003834-40 Sponsor Protocol Number: 07NR07 Start Date*: 2008-10-31
    Sponsor Name:UCL-INSTITUTE OF CHILD HEALTH
    Full Title: THE IMPACT OF REDUCING OVERTREATMENT ON QUALITY OF LIFE IN CHILDREN WITH REFRACTORY EPILEPSY
    Medical condition: We are studying a population of children with refractory epilepsy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004878-15 Sponsor Protocol Number: LAM115376 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline K.K. (GSK)
    Full Title: A multi-center, uncontrolled, open-label, evaluation of lamotrigine monotherapy in adult subjects with newly diagnosed epilepsy or recurrent epilepsy (currently untreated).
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016849-25 Sponsor Protocol Number: A0081047 Start Date*: 2010-03-15
    Sponsor Name:Pfizer Inc
    Full Title: A DOUBLE-BLIND, RANDOMIZED, MULTICENTER EFFICACY AND SAFETY STUDY OF PREGABALIN (LYRICA) AS MONOTHERAPY IN PATIENTS WITH PARTIAL SEIZURES
    Medical condition: Partial Seizures
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061334 Partial seizures LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005439-27 Sponsor Protocol Number: SP902 Start Date*: 2009-02-16
    Sponsor Name:UCB BIOSCIENCES, Inc.
    Full Title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-onset Seizures
    Medical condition: Partial-onset seizures (with or without secondary generalization)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10040703 Simple partial seizures PT
    14.0 10029205 - Nervous system disorders 10010145 Complex partial seizures PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) ES (Completed) AT (Completed) DK (Completed) PT (Not Authorised) IT (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002395-39 Sponsor Protocol Number: WN43174 Start Date*: 2022-05-24
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI-N-...
    Medical condition: NMDAR or LGI1 mediated autoimmune Encephalitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    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: 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
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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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