Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 31, 2012
October 4, 2013
December 2011
January 2015   (final data collection date for primary outcome measure)
Pure-tone threshold change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in hearing from baseline to after 3 months of treatment
Same as current
Complete list of historical versions of study NCT01526408 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Meniere's Disease
  • 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
  • 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 Comparator: Placebo Arm
    Treatment with 3 months of placebo
    Intervention: Drug: Placebo
  • Active Comparator: Active Arm
    Treatment with 3 months of active drug
    Intervention: Drug: Famciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
March 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01526408
HRI-003, Meniere's Disease
No
M. Jennifer Derebery, House Research Institute
House Research Institute
House Clinic
Principal Investigator: Jennifer Derebery, MD House Research Institute
House Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP