Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Autism Spectrum Disorder (ASD) AND Autism

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    47 result(s) found for: Autism Spectrum Disorder (ASD) AND Autism. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2007-006444-21 Sponsor Protocol Number: EC07/90076 Start Date*: 2009-02-13
    Sponsor Name:Fundación para la Investigación Biomédica Hospital Gregorio Marañón
    Full Title: EFFECT OF 8-WEEK FATTY ACIDS OMEGA-3 TREATMENT ON OXIDATIVE METABOLISM IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMISED DOUBLE-BLIND CROSSOVER PLACEBO-CONTROLLED TRIAL.
    Medical condition: autism spectrum disorders Trastornos del Espectro Autista
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063844 Autism spectrum disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005452-26 Sponsor Protocol Number: SMR-2728 Start Date*: 2015-11-19
    Sponsor Name:OptiNose AS
    Full Title: A randomized, placebo controlled, double-blind, double-dummy, 3-period cross-over study in adult patients with autism spectrum disorders evaluating cognitive response, eye-gaze, and heart rate vari...
    Medical condition: Autism spectrum disorder
    Disease: Version SOC Term Classification Code Term Level
    17.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Adults Gender: Male
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000586-45 Sponsor Protocol Number: S56327 Start Date*: 2014-05-08
    Sponsor Name:KU Leuven
    Full Title: Oxytocin-based pharmacotherapy for Autism Spectrum Disorders: Investigating the neural and behavioral effects of a promising intervention approach
    Medical condition: Young male adults with Autism Spectrum Disorders (18-30 years)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10003808 Autistic disorder LLT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    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: 2012-003750-89 Sponsor Protocol Number: KKS-186 Start Date*: 2013-02-14
    Sponsor Name:Philipps-University Marburg
    Full Title: A placebo-controlled, double blind, randomised trial with crossover-design investigating the effect of oxytocin nasal spray on neuronal processes of empathy
    Medical condition: high-functioning autism spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F 84.1)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004852 10021737 Infantile autism LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002819-21 Sponsor Protocol Number: GWND19189 Start Date*: Information not available in EudraCT
    Sponsor Name:GW Research Ltd
    Full Title: An exploratory, Phase 2, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P; CBD-OS) in children and adolescents with...
    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: DE (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-022511-18 Sponsor Protocol Number: X04 Start Date*: 2011-04-05
    Sponsor Name:Albert-Ludwig University Freiburg, Laboratory for Biological and Personality Psychology
    Full Title: Behavioral effects and neural correlates of oxytocin on social attention [Verhaltenseffekte und neuronales Korrelat von Oxytocin im Kontext sozialer Aufmerksamkeit]
    Medical condition: subjects with autism spectrum disorder and neurotypical controls
    Disease: Version SOC Term Classification Code Term Level
    12.1 10063844 Autism spectrum disorder LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003067-59 Sponsor Protocol Number: AOB/2013/01 Start Date*: 2017-01-25
    Sponsor Name:AZIENDA OSPEDALIERA G. BROTZU
    Full Title: A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003805 Autism LLT
    Population Age: Adults Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000254-28 Sponsor Protocol Number: RC31/19/0500 Start Date*: 2022-05-19
    Sponsor Name:University Hospital of Toulouse
    Full Title: Interest of oxytocin as an adjuvant treatment of psycho-educational measures in challenging behaviors in children with autism spectrum disorders and moderate to severe intellectual disability: feas...
    Medical condition: autism
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003805 Autism LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002875-81 Sponsor Protocol Number: NL58621.041.16 Start Date*: 2016-10-19
    Sponsor Name:UMC Utrecht
    Full Title: Bumetanide for the Autism Spectrum Clinical Effectiveness Trial
    Medical condition: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10008520 Childhood autism LLT
    20.0 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    20.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    20.0 10037175 - Psychiatric disorders 10061345 Pervasive developmental disorder LLT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    20.0 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    20.0 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002940-27 Sponsor Protocol Number: C2C-1 Start Date*: 2022-11-16
    Sponsor Name:Cell2Cure ApS
    Full Title: Effect of adipose tissue derived mesenchymal stromal cells on autism and leaky gut syndrome. A phase I pilot study.
    Medical condition: Children with autism spectrum disorder and gastrointestinal symptoms.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10008520 Childhood autism LLT
    20.1 100000004856 10013225 Disorder gastrointestinal LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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: 2016-000106-11 Sponsor Protocol Number: I14039 Start Date*: 2016-04-18
    Sponsor Name:Limoges Hospital
    Full Title: EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
    Medical condition: autism
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10003805 Autism PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-000769-35 Sponsor Protocol Number: S61358 Start Date*: 2018-09-27
    Sponsor Name:University Hospital, KU Leuven
    Full Title: In search for an innovative neural marker and intervention for socio-communicative difficulties in children with and without autism spectrum disorders
    Medical condition: Autism Spectrum Disorders
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003808 Autistic disorder LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001560-35 Sponsor Protocol Number: 2358 Start Date*: 2016-04-07
    Sponsor Name:Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
    Full Title: Bumetanide in Autism Medication and BIomarker study
    Medical condition: Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000723-40 Sponsor Protocol Number: 331-201-00148 Start Date*: 2024-06-13
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
    Medical condition: Irritability Associated With Autism Spectrum Disorder (ASD)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005388-32 Sponsor Protocol Number: ACP-103-070 Start Date*: 2022-07-05
    Sponsor Name:Acadia Pharmaceuticals Inc.
    Full Title: A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)
    Medical condition: Irritability associated with autistic disorder in children and adolescents with 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: FR (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004899-35 Sponsor Protocol Number: 331-201-00191 Start Date*: 2024-06-13
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectru...
    Medical condition: Irritability Associated With Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006531-26 Sponsor Protocol Number: 001-738 Start Date*: 2023-05-14
    Sponsor Name:Oslo University Hospital
    Full Title: A randomized, placebo-controlled, double-blind, 2-period cross-over study in youth with autism spectrum disorders evaluating social and repetitive behaviors after four weeks of twice daily-doses of...
    Medical condition: Autism spectrum disorders
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004378-32 Sponsor Protocol Number: WN39434 Start Date*: 2018-09-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase III, randomized, double-blind, placebo-controlled, efficacy, and safety study of Balovaptan in adults with Autism Spectrum Disorder with a 2 year open-label extension.
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    21.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 02 06:53:03 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA