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

ClinicalTrials.gov processed this data on March 24, 2021. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED - HAS RESULTS
 (See Contacts and Locations)
Verified March 2021 by House Research Institute, House Clinic, Inc.

Sponsor

House Research Institute

Information Provided by (Responsible Party)

M. Jennifer Derebery

Clinicaltrials.gov Identifier

NCT01526408
Other Study ID Numbers: HRI-003
First Submitted: January 31, 2012
First Posted: February 3, 2012
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021
Last Verified: March 2021
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Meniere's Disease
  • Drug: Famciclovir
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment11 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleTreatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir
Study Start DateDecember 2011
Actual Primary Completion DateJanuary 2015
Actual Study Completion DateMarch 2015

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Placebo Arm
    • Treatment with 3 months of placebo
  • Drug: Placebo
    • 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).

    Outcome Measures

    Primary Outcome Measures

    1. Pure-tone Threshold Change [3 months]
      Change in hearing from baseline to after 3 months of treatment

    Secondary Outcome Measures

    1. Tinnitus and/or Dizziness Handicap Change [3 months]
      Change in tinnitus and/or dizziness from baseline to after 3 months of treatment

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 90 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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

    Contacts and Locations

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

    More Information

    Additional Relevant MeSH Terms

    • Meniere Disease
    • Endolymphatic Hydrops
    • Labyrinth Diseases
    • Ear Diseases
    • Otorhinolaryngologic Diseases