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Clinical trials for Felbamate

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   44339   clinical trials with a EudraCT protocol, of which   7369   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: Felbamate. Displaying page 1 of 1.
    EudraCT Number: 2018-001180-23 Sponsor Protocol Number: 1042-CDD-3001 Start Date*: 2018-12-06
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults with Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed b...
    Medical condition: Treatment of seizures in children and young adults with genetically confirmed cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001337-41 Sponsor Protocol Number: YKP3089C025 Start Date*: 2018-12-17
    Sponsor Name:SK Life Science, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
    Medical condition: Primary Generalized Tonic-Clonic Seizures
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10018101 Generalised tonic-clonic seizures HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) BG (Completed) CZ (Completed) SK (Trial now transitioned) PL (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005344-27 Sponsor Protocol Number: YKP3089C040 Start Date*: 2022-02-03
    Sponsor Name:SK Life Science, Inc.
    Full Title: Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial-onset (Focal) Seizures
    Medical condition: partial onset (focal) seizures
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10016843 Focal seizures LLT
    21.1 10029205 - Nervous system disorders 10061334 Partial seizures PT
    20.0 10029205 - Nervous system disorders 10039910 Seizures LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004363-21 Sponsor Protocol Number: 1042-0603 Start Date*: 2015-03-11
    Sponsor Name:Marinus Pharmaceuticals, Inc
    Full Title: A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Foll...
    Medical condition: Drug-Resistant Epilepsy with Partial-Onset Seizures
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10065336 Partial epilepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004285-13 Sponsor Protocol Number: 1042-0500 Start Date*: 2007-05-11
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms.
    Medical condition: Infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021750 Infantile spasms LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-002481-40 Sponsor Protocol Number: TAK-935-3002 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 Adult Subj...
    Medical condition: Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000483-27 Sponsor Protocol Number: PRA/BIA-2093-302 Start Date*: 2004-08-19
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.
    Medical condition: Refractory partial epilepsy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    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 (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (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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