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Clinical trials for angelman 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    9 result(s) found for: angelman syndrome. Displaying page 1 of 1.
    EudraCT Number: 2013-002154-67 Sponsor Protocol Number: A-MANECE-2013 Start Date*: 2013-12-26
    Sponsor Name:Dra. Cristina Avendaño Solá
    Full Title: RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003787-48 Sponsor Protocol Number: BP41674 Start Date*: 2020-06-11
    Sponsor Name:F. Hoffmann-La Roche
    Full Title: AN OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7248824 IN PARTICIPANTS WITH ANGELMAN SYNDROME
    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: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003009-23 Sponsor Protocol Number: ION582-CS1 Start Date*: 2022-09-08
    Sponsor Name:IONIS PHARMACEUTICALS, INC.
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION582 in Patients with Angelman Syndrome
    Medical condition: Angelman syndrome is a neurogenetic disorder caused by a loss of function of the maternally inherited UBE3A gene (chromosome 15) which codes for UBE3A ubiquitin protein ligase. AS presents early in...
    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: IT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    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)
    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: 2021-001793-36 Sponsor Protocol Number: GTX-102-001 Start Date*: 2023-04-26
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Phase 1/2 Open-label, Multiple-dose, Dose-escalating Clinical Trial of the Safety and Tolerability of GTX-102 in Pediatric Patients With Angelman Syndrome (AS)
    Medical condition: Angelman Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003791-13 Sponsor Protocol Number: BP42992 Start Date*: 2022-01-11
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF 52 WEEKS OF TREATMENT WITH BASMISANIL IN CHILDREN WITH DUP15...
    Medical condition: Dup15q Syndrome
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004850 10083952 Dup15q syndrome LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) ES (Prematurely Ended) PT (Prematurely Ended) PL (Completed) NL (Ongoing)
    Trial results: (No results available)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001832-23 Sponsor Protocol Number: NEU_CH_7911 Start Date*: 2013-10-23
    Sponsor Name:Neurim Pharmaceuticals (1991) Ltd.
    Full Title: A RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF CIRCADIN® TO ALLEVIATE SLEEP DISTURBANCES IN CHILDREN WITH NEURODEVELOPMENTAL DISABILITIES
    Medical condition: SLEEP DISTURBANCES IN CHILDREN WITH NEURODEVELOPMENTAL DISABILITIES
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004873 10040997 Sleep disturbances LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA FI (Completed) GB (Completed) NL (Completed) FR (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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