Famvir for Treatment of Hearing in Unilateral Meniere's Disease

This study has been terminated.
(HRI no longer conducting research.)
Sponsor:
Collaborator:
House Clinic
Information provided by (Responsible Party):
M. Jennifer Derebery, House Research Institute
ClinicalTrials.gov Identifier:
NCT01526408
First received: January 31, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Meniere's Disease
Drug: Famciclovir
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir

Resource links provided by NLM:


Further study details as provided by House Research Institute:

Primary Outcome Measures:
  • Pure-tone threshold change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in hearing from baseline to after 3 months of treatment


Secondary Outcome Measures:
  • Tinnitus and/or dizziness handicap change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in tinnitus and/or dizziness from baseline to after 3 months of treatment


Enrollment: 11
Study Start Date: December 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Famvir

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526408

Sponsors and Collaborators
House Research Institute
House Clinic
Investigators
Principal Investigator: Jennifer Derebery, MD House Research Institute
  More Information

No publications provided

Responsible Party: M. Jennifer Derebery, Principal Investigator, House Research Institute
ClinicalTrials.gov Identifier: NCT01526408     History of Changes
Other Study ID Numbers: HRI-003, Meniere's Disease
Study First Received: January 31, 2012
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by House Research Institute:
Meniere's Disease
Vertigo
Hearing loss
Tinnitus
Anti-viral
Famciclovir

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Famciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014