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Clinical trials for Rett 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   44336   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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    11 result(s) found for: Rett syndrome. Displaying page 1 of 1.
    EudraCT Number: 2008-000787-16 Sponsor Protocol Number: C07-22 Start Date*: 2008-06-12
    Sponsor Name:Inserm
    Full Title: Etude pilote ouverte de l'effet de la fluoxetine chez des patientes agées de 8 à 28 ans atteintes du Syndrôme de Rett Typique
    Medical condition: Sydrome de Rett typique
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039000 Rett's disorder LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004345-32 Sponsor Protocol Number: ANAVEX2-73-RS-002 Start Date*: 2020-05-26
    Sponsor Name:Anavex Germany GmbH
    Full Title: A Double-Blind, Randomised, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients with Rett Syndrome
    Medical condition: Rett Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-001605-24 Sponsor Protocol Number: GWND19002 Start Date*: 2020-01-15
    Sponsor Name:GW Research Ltd
    Full Title: An open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-003370-27 Sponsor Protocol Number: GWND18064 Start Date*: 2019-04-09
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004448-20 Sponsor Protocol Number: Sarizotan/001/II/2015 Start Date*: 2016-11-28
    Sponsor Name:Newron Pharmaceuticals S.p.A.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Six-Month Study to Evaluate the Efficacy, Safety and Tolerability of Sarizotan in Patients with Rett Syndrome with Respiratory Symptoms
    Medical condition: Rett syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10039000 Rett's disorder LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-006739-30 Sponsor Protocol Number: 2007-37 Start Date*: 2008-07-31
    Sponsor Name:Assistance Publique Hopitaux de marseille
    Full Title: etude pilote des effets de la désipramine sur les parametres neurovégétatifs de l'enfant porteur de syndrome de rett
    Medical condition: la maladie de syndrome de Rett,
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-005021-76 Sponsor Protocol Number: OPBGC&RS_12_003 Start Date*: 2013-01-31
    Sponsor Name:EDISON PHARMACEUTICALS INC.
    Full Title: A Phase 2A Randomized, Placebo Controlled Trial of EPI-743 in Children with Rett Syndrome
    Medical condition: Rett Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10021605 Inborn errors of metabolism HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005571-10 Sponsor Protocol Number: 03-08-21-12 Start Date*: Information not available in EudraCT
    Sponsor Name:Kennedy Krieger Inst. Johns Hopkins Medicine
    Full Title: DEXTROMETORPHAN IN RETT SYNDROME
    Medical condition: Rett syndrome (RTT) is a neurological disorder with devastating consequences on the brain. It is characterized by stagnation of development followed by regression, both occurring between age 6 mont...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004420-30 Sponsor Protocol Number: CL3-95008-002 Start Date*: 2018-10-04
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder. A 6-month randomised, double-blind, placebo controlled mult...
    Medical condition: Autism Spectrum Disorder (ASD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) ES (Prematurely Ended) NL (Not Authorised) HU (Completed) PT (Completed) PL (Prematurely Ended) IE (Prematurely Ended) CZ (Completed) SK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004419-38 Sponsor Protocol Number: CL3-95008-001 Start Date*: 2018-10-04
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder. A 6-month randomised, double-blind, place...
    Medical condition: Autism Spectrum Disorder (ASD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Completed) ES (Prematurely Ended) NL (Completed) HU (Completed) PT (Completed) PL (Prematurely Ended) IT (Completed) IE (Prematurely Ended) CZ (Ongoing) SK (Completed)
    Trial results: View results
    EudraCT Number: 2020-005534-15 Sponsor Protocol Number: PRO-GLY-002/E2013 Start Date*: 2021-04-01
    Sponsor Name:Proveca Pharma LTD
    Full Title: Double-blind, placebo-controlled, randomized clinical trial comparing the efficacy and safety of Sialanar plus oral rehabilitation against placebo plus oral rehabilitation for children and adolesce...
    Medical condition: Severe sialorrhoea and neurodisabilties in children
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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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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