Famvir for Treatment of Hearing in Unilateral Meniere's Disease

House Research Institute

Status and phase: Terminated; Phase 3

Conditions: Meniere's Disease

Treatments: Drug: Famciclovir; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01526408

Meniere's Disease (Other Identifier)

HRI-003

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

Treatment with 3 months of placebo

Treatment:

Drug: Placebo

Active Arm

Active Comparator group

Description:

Treatment with 3 months of active drug

Treatment:

Drug: Famciclovir