Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy

This study has been completed.
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: December 21, 2006
Last verified: December 2006
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.

Condition Intervention Phase
Meniere's Disease
Drug: Betahistine 24 mg bid (Betaserc)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Patients who have undergone vestibular neurotomy for the treatment of disabling Menière’s disease and who have confirmed vestibular areflexia

Secondary Outcome Measures:
  • Other peripheral vestibular disease than Menière’s disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women

Estimated Enrollment: 20
Study Start Date: January 2003

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia

Exclusion Criteria:

  • Other peripheral vestibular disease than Menière’s disease
  • Central vestibular disease
  • Neurological disease
  • Contraindication to betahistine
  • Pregnant or lactating women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00160238

Site 1
Marseille, France
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00160238     History of Changes
Other Study ID Numbers: S108.4.102 
Study First Received: September 9, 2005
Last Updated: December 21, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Solvay Pharmaceuticals:
Meniere's disease
Vestibular neurotomy

Additional relevant MeSH terms:
Meniere Disease
Ear Diseases
Endolymphatic Hydrops
Labyrinth Diseases
Otorhinolaryngologic Diseases
Histamine Agents
Histamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on May 30, 2016