Meniere's Disease
Conditions
Keywords
Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, 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.
Interventions
DRUGFamciclovir
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).
DRUGPlacebo
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).
Sponsors
House Clinic, Inc.
House Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pure-tone Threshold Change | 3 months | Change in hearing from baseline to after 3 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus and/or Dizziness Handicap Change | 3 months | Change in tinnitus and/or dizziness from baseline to after 3 months of treatment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm Treatment with 3 months of placebo
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). | 0 |
| Active Arm Treatment with 3 months of active 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). | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pure-tone Threshold Change
Change in hearing from baseline to after 3 months of treatment
Time frame: 3 months
Population: early termination of study and sponsor organization closed
Secondary
Tinnitus and/or Dizziness Handicap Change
Change in tinnitus and/or dizziness from baseline to after 3 months of treatment
Time frame: 3 months
Population: early termination of study and sponsor organization closed