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Clinical trials for Gaboxadol

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    5 result(s) found for: Gaboxadol. Displaying page 1 of 1.
    EudraCT Number: 2004-001265-18 Sponsor Protocol Number: LU 02-030 study No. 10403 Start Date*: 2005-04-05
    Sponsor Name:H. Lundbeck A/S
    Full Title: Protocol title No.10403: A double-blind, randomised, placebo-controlled, parallel-group, Phase III study evaluating the efficacy and safety of gaboxadol 5 mg and 10 mg daily in elderly outpatients ...
    Medical condition: Elderly outpatients with primary insomnia, diagnosed according to DSM IV -TR
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001264-45 Sponsor Protocol Number: LU 02-030 study No. 10402: Start Date*: 2005-04-06
    Sponsor Name:H. Lundbeck A/S
    Full Title: Protocol title study No. 10402: A 12-month Phase III safety study of gaboxadol 10 mg daily consisting of a 6-month double-blind, randomised, placebo-controlled, parallel-group periodfollowed by a...
    Medical condition: Elderly outpatients with primary insomnia, diagnosed according to DSM IV-TR
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004478-24 Sponsor Protocol Number: OV101-18-002 Start Date*: 2020-06-05
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-000506-36 Sponsor Protocol Number: 12213A Start Date*: 2009-03-13
    Sponsor Name:H. Lundbeck A/S
    Full Title: Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose comparison study of escitalopram in combination with two fixed doses of gaboxadol to escitalopram in Major Depressive Disorder
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025453 Major depressive disorder NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002907-17 Sponsor Protocol Number: OV101-19-001 Start Date*: 2020-02-19
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: A MulticeNter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in PediaTric IndividUals With AngelmaN SyndromE (NEPTUNE)
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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