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Clinical trials for Betahistine

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   44346   clinical trials with a EudraCT protocol, of which   7374   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: Betahistine. Displaying page 1 of 1.
    EudraCT Number: 2008-001840-38 Sponsor Protocol Number: BET207 Start Date*: 2008-08-05
    Sponsor Name:OBEcure
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Female Subjects
    Medical condition: obesity
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029883 Obesity LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) NL (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002474-52 Sponsor Protocol Number: AM-125-CL-18-01 Start Date*: 2019-04-01
    Sponsor Name:Auris Medical AG
    Full Title: Multicenter randomized controlled phase 2 trial to evaluate AM-125 in the treatment of acute peripheral vertigo following neurosurgery (TRAVERS)
    Medical condition: Treatment of acute peripheral vertigo
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10059614 Vestibular vertigo LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) PL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005246-42 Sponsor Protocol Number: 0796-19 Start Date*: 2021-12-28
    Sponsor Name:INTAS PHARMACEUTICALS LIMITED
    Full Title: A Multicenter, Three- arm, Double- blind, Double dummy, Parallel-group, placebo controlled Study for efficacy and safety evaluation of prolonged release formulation of Betahistine PR 48 mg once dai...
    Medical condition: Menière´s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10047340 Vertigo PT
    20.0 10013993 - Ear and labyrinth disorders 10022398 Inner ear signs and symptoms HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005122-33 Sponsor Protocol Number: NIMOBET-1 Start Date*: 2014-03-04
    Sponsor Name:MDM S.p.A.
    Full Title: A phase II, randomized, double-blind, parallel groups study to assess the efficacy and safety of Nimodipine 20 mg + Betahistine 16 mg versus Placebo + Betahistine 16 mg in the treatment of vertigo
    Medical condition: Vertigo
    Disease: Version SOC Term Classification Code Term Level
    16.1 10013993 - Ear and labyrinth disorders 10047340 Vertigo PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-000885-21 Sponsor Protocol Number: BETA Start Date*: 2008-03-25
    Sponsor Name:TNO
    Full Title: The effect of betahistine 48 mg three times daily on motion sickness
    Medical condition: This study will evaluate the impact of betahistine on motion sickness.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027990 Motion sickness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-013702-14 Sponsor Protocol Number: BETNV009 Start Date*: 2010-08-13
    Sponsor Name:Hospital of the University of Munich
    Full Title: Effects of betahistine on central vestibular compensation in acute unilateral vestibular failure: a double-blind, placebo-controlled trial
    Medical condition: vestibular failure (vestibular neuritis)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10013993 - Ear and labyrinth disorders 10047386 Vestibular disorder PT
    18.0 10029205 - Nervous system disorders 10029240 Neuritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004025-27 Sponsor Protocol Number: Antivert1-B09_PE_V1.0 Start Date*: 2013-02-15
    Sponsor Name:HENNIG ARZNEIMITTEL GmbH & Co. KG
    Full Title: Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-b...
    Medical condition: Vertigo of peripheral origin
    Disease: Version SOC Term Classification Code Term Level
    15.0 10013993 - Ear and labyrinth disorders 10031615 Other and unspecified peripheral vertigo LLT
    14.1 10013993 - Ear and labyrinth disorders 10058708 Rotatory vertigo LLT
    14.1 10013993 - Ear and labyrinth disorders 10047344 Vertigo labyrinthine PT
    14.1 10013993 - Ear and labyrinth disorders 10034641 Peripheral vertigo, unspecified LLT
    15.0 10013993 - Ear and labyrinth disorders 10032379 Other peripheral vertigo LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-000444-13 Sponsor Protocol Number: X16012008 Start Date*: 2008-04-08
    Sponsor Name:Finnish Defence Forces
    Full Title: Äkillisen akustisen vamman hoito ylipaineisella happihoidolla ja lääkkeillä: Prospektiivinen satunnaistettu ja kontrolloitu tutkimus vamman saaneilla varusmiehillä.
    Medical condition: Acustic or barotraumas after gun accident in conscripts
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061688 Barotrauma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-000752-32 Sponsor Protocol Number: 04T-617 Start Date*: 2006-01-23
    Sponsor Name:Klinikum Grosshadern
    Full Title: Medical treatment of Menière’s disease with betahistine: a placebo-controlled, dose-finding study
    Medical condition: Ménière’s disease is a disorder of the inner ear membranous labyrinth characterized by paroxysmal vertiginous attacks, fluctuating sensorineural hearing loss, aural fullness, and tinnitus .The unde...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027183 Meniere's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001337-86 Sponsor Protocol Number: 104-201403 Start Date*: 2014-07-11
    Sponsor Name:Otonomy Inc.
    Full Title: A 6-month, prospective, randomized, multicenter, placebo-controlled safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere's disease, foll...
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-001464-35 Sponsor Protocol Number: 104-201811 Start Date*: 2018-11-06
    Sponsor Name:Otonomy, Inc.
    Full Title: A prospective, randomized, double blind, placebo-controlled, multicenter, Phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’...
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) IT (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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