Famvir for Treatment of Hearing in Unilateral Meniere's Disease

This study is currently recruiting participants.

Verified April 2013 by House Research Institute

Sponsor:

Information provided by (Responsible Party):

House Research Institute

ClinicalTrials.gov Identifier:

NCT01526408

First received: January 31, 2012

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2012

Last Updated Date

April 9, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pure-tone threshold change [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Change in hearing from baseline to after 3 months of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01526408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Famvir for Treatment of Hearing in Unilateral Meniere's Disease

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Meniere's Disease

Intervention ^ICMJE

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).

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roberta Leyvas	213-273-8025	rleyvas@hei.org
Contact: Jennifer Derebery, MD		jderebery@hei.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01526408

Other Study ID Numbers ^ICMJE

HRI-003, Meniere's Disease

Has Data Monitoring Committee

Responsible Party

House Research Institute

Study Sponsor ^ICMJE

House Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jennifer Derebery, MD

House Research Institute

Information Provided By

House Research Institute

Verification Date

April 2013

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

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