NCT01526408

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Typical duration for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

January 31, 2012

Results QC Date

March 24, 2021

Last Update Submit

March 24, 2021

Conditions

Meniere's Disease

Keywords

Meniere's DiseaseVertigoHearing lossTinnitusAnti-viralFamciclovir

Outcome Measures

Primary Outcomes (1)

  • Pure-tone Threshold Change

    Change in hearing from baseline to after 3 months of treatment

    3 months

Secondary Outcomes (1)

  • Tinnitus and/or Dizziness Handicap Change

    3 months

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Treatment with 3 months of placebo

Drug: Placebo

Active Arm

ACTIVE COMPARATOR

Treatment with 3 months of active drug

Drug: Famciclovir

Interventions

FamciclovirDRUG

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).

Also known as: Famvir
Active Arm
PlaceboDRUG

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).

Placebo Arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral Meniere's Disease
  • 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

You may not qualify if:

  • Acute or chronic middle ear disease in either ear
  • Only hearing ear
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meniere DiseaseVertigoHearing LossTinnitus

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesVestibular DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersSensation Disorders

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Mahta Marefat
Organization
House Institute Foundation
mmarefat@hifla.org
(213) 770-1808

Study Officials

  • Jennifer Derebery, MD

    House Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 19, 2021

Results First Posted

April 19, 2021

Record last verified: 2021-03