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Clinical trials for Betaine

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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    4 result(s) found for: Betaine. Displaying page 1 of 1.
    EudraCT Number: 2008-004641-29 Sponsor Protocol Number: VAS07BE Start Date*: 2008-10-21
    Sponsor Name:VAS VASCULAR INDEPENDENT RESEACH AND EDUCATION EUROPEAN ORGANIZATION. C/O UNIV MILANO. OSP. L. SACCO
    Full Title: Non profit study of phase II randomized, double blind, placebo controlled, parallel groups, dose-finding trial with 3 different doses of Betaine versus placebo in subjects affected by PAD (Peripher...
    Medical condition: Leriche-Fontaine stage II PAD presenting symptoms of intermittent claudication
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013283 Disorder vascular peripheral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001039-30 Sponsor Protocol Number: BetHäm2012 Start Date*: 2013-03-06
    Sponsor Name:Hospital of Goethe-Universitiy
    Full Title: BetHäm2012: A monocenter, single-blind, randomized, 2-armed, placebo-controlled, cross-over study to investigate coagulation markers in patients with haemophilia A after administration of Betain
    Medical condition: In this study patients with haemophilia A are included.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004791-19 Sponsor Protocol Number: CACN00177-100D Start Date*: 2020-05-11
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: A Phase 1/2 Multiple Ascending-Dose Study in Subjects With Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of ACN00177
    Medical condition: Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10020365 Homocystinuria PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-000614-21 Sponsor Protocol Number: 7168K01 Start Date*: 2007-08-09
    Sponsor Name:Zambon Group S.p.A
    Full Title: A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenit...
    Medical condition: homocystinuria
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020365 pref
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) HU (Completed) GB (Prematurely Ended)
    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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