Trial document




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  DRKS00005039

Trial Description

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Title

Effects of betahistine on central vestibular compensation in acute unilateral vestibular failure: a double-blind, placebo-controlled trial

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Trial Acronym

BETAVEST

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URL of the Trial

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Brief Summary in Lay Language

To date there is no approved drug treatment available for patients with acute vestibular failure.
Research question: Do patients receving betahistin show better/faster recovery from acute unilateral vestibular failure.

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Brief Summary in Scientific Language

Primary Objective: To demonstrate medium-term and short-term superiority of betahistine treatment regarding recovery of postural control or spontaneous nystagmus as compared to placebo.
Secondary Objectives:
To establish a patient-oriented endpoint “time to recovery from acute symp-toms of acute vestibular neuritis” for phase III trials and to demonstrate faster recovery after betahistine treatment than after placebo. (Key secondary objective)
To analyze whether superiority of betahistine treatment is kept up to the end of treatment. To quantitatively describe/compare recovery over time vs. placebo and to determine optimal treatment duration. To shed light on the underlying mechanisms (i. e., peripheral vs. central compensation). To check for the occurrence of the adverse effects reported in the summary of the medical product characteristics (SmPC) of the drug.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005039
  •   2013/08/23
  •   2010/08/13
  •   yes
  •   Approved
  •   128-10 fed, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   2009-013702-14 
  •   2009-013702-14  (EU-CTR)
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Health Condition or Problem studied

  •   H81.2 -  Vestibular neuronitis
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Interventions/Observational Groups

  •   betahistine dihydrochloride (Vasomotal(R)) 3 times 48 mg per day orally up to 4 weeks
  •   placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   II-III
  •   Yes
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Primary Outcome

"Total sway path" (length per time) on a compliant foam-padded posturography
platform for postural control on day 3 and 10 after randomization

Peak slow phase velocity of the spontaneous
nystagmus on day 3 and 10 after randomization

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Secondary Outcome

"subjective visual vertical" on day 1, 3, 10, 28 and 56 after randomization

slow phase velocity of nystagmus provoked by caloric irrigation on day 1 and 56 after randomization

handicap / impairment due to vertigo or dizziness assessed by the Dizziness Handicap Inventory (questionnaire) on day 1, 10, 28 and 56 after randomization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2010/12/17
  •   210
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patient has a history of acute/sub-acute (i.e., within minutes to hours) on-set of severe prolonged rotatory vertigo, nausea, and postural imbalance;
• the clinical examination reveals horizontal-rotatory spontaneous nystag-mus (fast phase) toward the unaffected ear without evidence of a central vestibular lesion, and a pathological head-impulse test (i.e., turning the head of the patient rapidly to the right and left while observing provoked compensatory eye movements) that reveals an ipsilateral deficit of the horizontal semicircular canal (Halmagyi & Curthoys 1988);
• caloric irrigation shows hypo-/unresponsiveness of the horizontal canal of the affected ear, i.e., the maximum slow phase velocity during caloric irri-gation with 30°C and 44°C water should be less than 3°/s on the affected side and the asymmetry between the two sides is >25 percent according to “Jongkees’s vestibular paresis formula” (Jongkees et al. 1962; Fife et al. 2000); and
• there is a displacement of the subjective visual vertical toward the affected ear without any vertical divergence of the eyes, i.e., without vertical devia-tion of one eye above the other (Cnyrim et al. 2008).
• Written informed consent

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Exclusion Criteria

• Patients not able to give consent;
• a history of vestibular dysfunction before the acute symptom onset or ves-tibular symptoms beginning more than 3 days before patients were re-cruited;
• additional cochlear symptoms, i.e., tinnitus or acute hearing loss before, during, or after the onset of vertigo;
• central ocular motor or central vestibular dysfunction;
• any other brainstem or cerebellar signs or symptoms or abnormal findings on the MRI in the brainstem or cerebellum in diffusion-weighted images or hyperintense lesions in T2-weighted images in combination with contrast enhancement in T1-weighted images;
• other known vestibular disorders such as vestibular migraine, Menière´s disease/syndrome, phobic postural vertigo, benign paroxysmal positioning vertigo;
• central disorders such as paroxysmal brainstem attacks;
• contraindications for treatment with betahistine-dihydrochloride such as bronchial asthma, pheochromocytoma,
• pregnancy or breast-feeding,
• severe dysfunction of liver or kidney, ulcer of the stomach or duodenum,
• treatment with other antihistaminic drugs;
• known severe coronary heart disease or heart failure;
• persistent hypertension with systolic blood pressure > 180 mmHg or dias-tolic BP > 110 mmHg that cannot be controlled by antihypertensive thera-py;
• life expectancy < 3 months, other serious illness, e.g., severe hepatic, cardiac or renal failure, acute myocardial infarction, neoplasm or a com-plex disease that may confound treatment assessment.
• The patient has received any investigational medication within 30 days prior to administration of trial medication or is scheduled to receive an in-vestigational drug up to 30 days after end of trial.
• The patient was previously admitted to this trial or simultaneous participa-tion in another clinical trial or participation in any clinical trial involving anadministration of investigational medicinal product within 30 days prior to clinical trial beginning.

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern Deutsches Schwindel- und Gleichgewichtszentrum (IFB) Studienzentrale
    • Mr.  Privdoz. Dr. med., MPH  Otmar  Bayer 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern Deutsches Schwindel- und Gleichgewichtszentrum (IFB) Studienzentrale
    • Studienzentrale  DSGZ 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2016/06/10
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Trial Publications, Results and other Documents

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