Famvir for Treatment of Hearing in Unilateral Meniere's Disease

Meniere's Disease Clinical Trial

— Famvir  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01526408
• Other study ID #: HRI-003
• Secondary ID: Meniere's Diseas
• Status: Terminated
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2021
• Source: House Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
House Research Institute	House Clinic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pure-tone Threshold Change	Change in hearing from baseline to after 3 months of treatment	3 months
Secondary	Tinnitus and/or Dizziness Handicap Change	Change in tinnitus and/or dizziness from baseline to after 3 months of treatment	3 months