Famvir for Treatment of Hearing in Unilateral Meniere's Disease (Famvir)

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

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.

Study Overview

• Status: Terminated
• Conditions: Meniere's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Famciclovir

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; Treatment with 3 months of placebo	Drug: Placebo; 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).
Active Comparator: Active Arm; Treatment with 3 months of active drug	Drug: Famciclovir; 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).; 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

Collaborators and Investigators

• Sponsor: House Research Institute
• Collaborators: House Clinic, Inc.
• Investigators: Principal Investigator: Jennifer Derebery, MD, House Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Vertigo; Tinnitus; Hearing loss; Meniere's Disease; Anti-viral; Famciclovir
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Meniere Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Famciclovir
• Other Study ID Numbers: HRI-003; Meniere's Disease (Other Identifier: House Research Institute)