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Clinical trials for Dexpramipexole

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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    5 result(s) found for: Dexpramipexole. Displaying page 1 of 1.
    EudraCT Number: 2022-003004-33 Sponsor Protocol Number: AR-DEX-22-01 Start Date*: 2023-04-26
    Sponsor Name:Areteia Therapeutics, Inc.
    Full Title: A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe ...
    Medical condition: Severe Eosinophilic Asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10068462 Eosinophilic asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003005-30 Sponsor Protocol Number: AR-DEX-22-03 Start Date*: 2023-06-28
    Sponsor Name:Areteia Therapeutics, Inc.
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 24 weeks in participants with eosinop...
    Medical condition: Eosinophilic Asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10068462 Eosinophilic asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-006119-70 Sponsor Protocol Number: 223AS304 Start Date*: 2012-05-15
    Sponsor Name:Biogen Idec Research Limited
    Full Title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis
    Medical condition: Amyotrophic Lateral Sclerosis (ALS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) IE (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) NL (Prematurely Ended) GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022818-19 Sponsor Protocol Number: 223AS302 Start Date*: 2011-03-22
    Sponsor Name:Biogen Idec Limited
    Full Title: A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.
    Medical condition: amyotrophic lateral sclerosis (ALS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) SE (Completed) IE (Completed) ES (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003013-34 Sponsor Protocol Number: UOL0730 Start Date*: 2020-03-02
    Sponsor Name:University of Leicester
    Full Title: Beyond Allergic Th2 Severe Asthma
    Medical condition: T2-High and T2-Low severe asthma
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10005503 Blood eosinophils LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    21.1 100000004865 10049868 Asthma exacerbation prophylaxis LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10068462 Eosinophilic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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