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Famvir for Treatment of Hearing in Unilateral Meniere's Disease (Famvir)

Primary Purpose

Meniere's Disease

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Famciclovir
Placebo
Sponsored by
House Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, Famciclovir

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo Arm

    Active Arm

    Arm Description

    Treatment with 3 months of placebo

    Treatment with 3 months of active drug

    Outcomes

    Primary Outcome Measures

    Pure-tone Threshold Change
    Change in hearing from baseline to after 3 months of treatment

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 31, 2012
    Last Updated
    March 24, 2021
    Sponsor
    House Research Institute
    Collaborators
    House Clinic, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01526408
    Brief Title
    Famvir for Treatment of Hearing in Unilateral Meniere's Disease
    Acronym
    Famvir
    Official Title
    Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Terminated
    Why Stopped
    HRI no longer conducting research.
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    House Research Institute
    Collaborators
    House Clinic, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meniere's Disease
    Keywords
    Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, Famciclovir

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Treatment with 3 months of placebo
    Arm Title
    Active Arm
    Arm Type
    Active Comparator
    Arm Description
    Treatment with 3 months of active drug
    Intervention Type
    Drug
    Intervention Name(s)
    Famciclovir
    Other Intervention Name(s)
    Famvir
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Pure-tone Threshold Change
    Description
    Change in hearing from baseline to after 3 months of treatment
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Tinnitus and/or Dizziness Handicap Change
    Description
    Change in tinnitus and/or dizziness from baseline to after 3 months of treatment
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Derebery, MD
    Organizational Affiliation
    House Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Famvir for Treatment of Hearing in Unilateral Meniere's Disease

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