Status:
TERMINATED
Famvir for Treatment of Hearing in Unilateral Meniere's Disease
Lead Sponsor:
House Research Institute
Collaborating Sponsors:
House Clinic, Inc.
Conditions:
Meniere's Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01526408
Start Date
December 1 2011
End Date
March 1 2015
Last Update
April 19 2021
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