Famvir for Treatment of Hearing in Unilateral Meniere's Disease

Study Overview
=================
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.

Official Title
-----------------
Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: Famciclovir
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>Treatment with 3 months of placebo | Drug: Placebo<br>* Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).<br>|
| Active Comparator: Active Arm<br>Treatment with 3 months of active drug | Drug: Famciclovir<br>* Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).<br>* Other names: Famvir;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure-tone Threshold Change | Change in hearing from baseline to after 3 months of treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus and/or Dizziness Handicap Change | Change in tinnitus and/or dizziness from baseline to after 3 months of treatment | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, Famciclovir