Famvir for Treatment of Hearing in Unilateral Meniere's Disease

Phase 3

Terminated

• Conditions: Meniere's Disease
• Interventions: Drug: Placebo; Drug: Famciclovir

• Registration Number: NCT01526408
• Lead Sponsor: House Research Institute

Brief Summary

The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2021-03
• Results First Submitted: 2021-03-24
• Results First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Results First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Unilateral Meniere's Disease
• 2 vertigo episodes of at least 20 minutes
• Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
• Less than 45 dB 4-frequency pure-tone average in the affected ear
• Tinnitus and/or aural fullness
• Willing to undergo the clinical trial procedures
• Signed informed consent

Exclusion Criteria

• Acute or chronic middle ear disease in either ear
• Only hearing ear
• 4-frequency pure-tone average > 45 dB in either ear
• Known allergy to famciclovir or any of the ingredients in the formulation
• Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
• Must not have had previous inner ear surgery
• History of immunodeficiency diseases such as HIV
• History of renal insufficiency or other kidney diseases
• A female of child-bearing potential who is pregnant
• History of noncompliance to medical regimens
• Unwilling to or unable to comply with the protocol, including scheduling study evaluations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Treatment with 3 months of placebo
Active Arm	Famciclovir	Treatment with 3 months of active drug

Primary Outcome Measures

Name	Time	Method
Pure-tone Threshold Change	3 months	Change in hearing from baseline to after 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
Tinnitus and/or Dizziness Handicap Change	3 months	Change in tinnitus and/or dizziness from baseline to after 3 months of treatment