Famvir for Treatment of Hearing in Unilateral Meniere's Disease

NCT01526408 — Phase 3, Terminated, 11 participants, House Research Institute

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

Registry	NCT01526408, acronym Famvir
Status	Terminated - HRI no longer conducting research.
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	11 (Actual)
Sponsor	House Research Institute (Other); collaborators: House Clinic, Inc.
Conditions	Meniere's Disease
Interventions	Famciclovir, Placebo (Drug)
Dates	start 2011-12-01, primary completion 2015-01-01, completion 2015-03-01, first posted 2012-02-03, last updated 2021-04-19

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo Arm	Placebo comparator	Drug: Placebo	Treatment with 3 months of placebo
Active Arm	Active comparator	Drug: Famciclovir	Treatment with 3 months of active drug

Famciclovir (Drug), also known as Famvir: 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).
Placebo (Drug): 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).

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Posted results

Participant flow

Milestone	Placebo Arm	Active Arm
Started	0	0
Completed	0	0
Not completed	0	0

Outcome results

Pure-tone Threshold Change (Primary)
Tinnitus and/or Dizziness Handicap Change (Secondary)

Adverse events

Time frame: early termination of study and sponsor organization closed

Arm	Deaths	Serious adverse events	Other adverse events
Placebo Arm	0	0	0
Active Arm	0	0	0

+Investigators

Jennifer Derebery, MD, Principal investigator, House Research Institute