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Clinical trials for Lennox-Gastaut 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
  • 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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Bentzinger C*,Biziere K,Plovin P,Dulac O,Chiron C,Girod R,Hewson G,Metcalfe S,Siegel J L, Clinical Final Study Report: Open-label exploratory study of the effects of acute i.v. flumazenil on interictal epileptic activity in pediatric patients with treated or untreated Lennox-Gastaut syndrome
    Active substance: FLUMAZENIL
    Study summary document link (including results):
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    Document reference: 28213
    Study title: Nitrazepam for refractory infantile spasms and the Lennox-Gastaut syndrome.
    Active substance: NITRAZEPAM
    Study summary document link (including results):
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    Document reference: 32656
    Study title: Nitrazepam for the treatment of Lennox-Gastaut syndrome.
    Active substance: NITRAZEPAM
    Study summary document link (including results):
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    Document reference: 32655
    Study title: 8. Phase 3, open-label, PK, safety, and tolerability study of TPM adjunctive therapy in pediatric subjects with Lennox-Gastaut syndrome
    Active substance: TOPIRAMATE
    Study summary document link (including results):
    View full study record
    Document reference: 44841
    Study title: 9. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with Lennox-Gastaut syndrome
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44842
    Study title: 13. Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44877
    Study title: Open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjectswith Lennox-Gastaut syndrome
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44898
    Study title: Phase 3, open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjects with Lennox-Gastaut syndrome.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
    View full study record
    Document reference: 44897
    Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44886
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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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