Trial record 4 of 7 for:
Open Studies | "Meniere Disease"
Famvir for Treatment of Hearing in Unilateral Meniere's Disease
This study is currently recruiting participants.
Verified April 2013 by House Research Institute
Sponsor:
House Research Institute
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meniere's Disease |
Drug: Famciclovir Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir |
Resource links provided by NLM:
Further study details as provided by House Research Institute:
Primary Outcome Measures:
- Pure-tone threshold change [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in hearing from baseline to after 3 months of treatment
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 44 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Arm
Treatment with 3 months of placebo
|
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).
|
|
Active Comparator: Active Arm
Treatment with 3 months of active drug
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526408
Contacts
| Contact: Roberta Leyvas | 213-273-8025 | rleyvas@hei.org |
| Contact: Jennifer Derebery, MD | jderebery@hei.org |
Locations
| United States, California | |
| House Research Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Principal Investigator: Jennifer Derebery, MD | |
Sponsors and Collaborators
House Research Institute
Investigators
| Principal Investigator: | Jennifer Derebery, MD | House Research Institute |
More Information
No publications provided
| Responsible Party: | House Research Institute |
| ClinicalTrials.gov Identifier: | NCT01526408 History of Changes |
| Other Study ID Numbers: | HRI-003, Meniere's Disease |
| Study First Received: | January 31, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by House Research Institute:
|
Meniere's Disease Vertigo Hearing loss |
Tinnitus Anti-viral Famciclovir |
Additional relevant MeSH terms:
|
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |
Famciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013