Trial | NCT01526408  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    famciclovir ...

  • Study Participants

    11
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 Started
Dec 31
2011
Primary Completion
Jan 31
2015
Study Completion
Mar 31
2015
Results Posted
Apr 19
2021
Last Update
Apr 19
2021

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

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).

Placebo Arm Placebo Comparator

Treatment with 3 months of placebo

Active Arm Active Comparator

Treatment with 3 months of active drug

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

Summary

Placebo Arm

Active Arm

All Events

Event Type Organ System Event Term

Pure-tone Threshold Change

Change in hearing from baseline to after 3 months of treatment

Placebo Arm

Active Arm

Tinnitus and/or Dizziness Handicap Change

Change in tinnitus and/or dizziness from baseline to after 3 months of treatment

Placebo Arm

Active Arm

Total

0
Participants