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NCT00160238 Clinical Trial

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

Meniere's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160238
Other study ID # S108.4.102
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated December 21, 2006
Start date January 2003

Study information
Verified date December 2006
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Betahistine 24 mg bid (Betaserc)

Locations
Country Name City State
France Site 1 Marseille

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients who have undergone vestibular neurotomy for the treatment of disabling Menière’s disease and who have confirmed vestibular areflexia
Secondary Other peripheral vestibular disease than Menière’s disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women
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