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

• Sponsor: Solvay Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00160238
• Collaborator: (none)
• Enrollment: 20
• Location: 1

Study Details

Study Description

Brief 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.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Jan 1, 2003

Outcome Measures

Primary Outcome Measures

1. Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia []

Secondary Outcome Measures

1. Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Site 1	Marseille		France

Sponsors and Collaborators

• Solvay Pharmaceuticals

Investigators

• Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00160238
• Other Study ID Numbers: S108.4.102
• First Posted: Sep 12, 2005
• Last Update Posted: Dec 22, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: Meniere's disease; Vestibular neurotomy
• Additional relevant MeSH terms: Meniere Disease; Betahistine

Study Results

No Results Posted as of Dec 22, 2006