Meniere's DiseasePhase 3FamvirNCT01526408

Famvir for Treatment of Hearing in Unilateral Meniere's Disease

A Phase 3 study testing Famciclovir in people with Meniere's Disease, run by House Research Institute.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Meniere's Disease
What is being tested?: Famciclovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: No sites listed yet
Study dates: Dec 2011to Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

About this study

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

Conditions: Meniere's Disease
Being tested: Famciclovir, Placebo
Keywords: Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, Famciclovir
Medical subject headings: Meniere Disease, Vertigo, Hearing Loss, Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FamciclovirDrug
Also called Famvir
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).
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).

Study groups in NCT01526408
Study group	Role	What they receive
Placebo Arm	Placebo comparator	Treatment with 3 months of placebo Receives: Drug: Placebo
Active Arm	Active comparator	Treatment with 3 months of active drug Receives: Drug: Famciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Pure-tone Threshold Change
Change in hearing from baseline to after 3 months of treatment
Measured: 3 months

Secondary outcomes (1)

Tinnitus and/or Dizziness Handicap Change
Change in tinnitus and/or dizziness from baseline to after 3 months of treatment
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Mar 2015

First posted3 Feb 2012 (estimated)
Study startDec 2011
Primary completionJan 2015
Study completionMar 2015

Why it stopped: HRI no longer conducting research.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01526408
Sponsor's protocol ID: HRI-003
Other IDs: Meniere's Disease
Acronym: Famvir
Status last verified: Mar 2021
First submitted: 31 Jan 2012
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

All Meniere's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir
ClinicalTrials.gov ID: NCT01526408
Acronym / sponsor ID: Famvir / HRI-003
Conditions: Meniere's Disease
Keywords: Meniere's Disease, Vertigo, Hearing loss, Tinnitus, Anti-viral, Famciclovir
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: HRI no longer conducting research.
Enrolment: 11 participants (actual)
Lead sponsor: House Research InstituteUniversity, hospital or other
Collaborators: House Clinic, Inc.
Study start: Dec 2011
Primary completion: Jan 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 3 Feb 2012 (estimated)
Results: Posted 19 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Arm	Placebo comparator	Drug: PlaceboTreatment with 3 months of placebo
Active Arm	Active comparator	Drug: FamciclovirTreatment with 3 months of active drug

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FamciclovirAlso: FamvirPatients 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).	Drug	Active Arm
PlaceboPatients 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).	Drug	Placebo Arm

Primary outcome

Pure-tone Threshold Change
Time frame: 3 months
Change in hearing from baseline to after 3 months of treatment

1 secondary outcome

Tinnitus and/or Dizziness Handicap Change
Time frame: 3 months

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Arm	0	0
Active Arm	0	0

Primary outcome: Pure-tone Threshold Change

Time frame: 3 months

Population analysed: early termination of study and sponsor organization closed

1 secondary outcome is reported in the full results.

Adverse events

Time frame: early termination of study and sponsor organization closed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Arm	0 of 0	0 of 0	0
Active Arm	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meniere's Disease

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Derebery, MD principal investigator

House Research Institute

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Famciclovir in people with Meniere's Disease, run by House Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pure-tone Threshold Change (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01526408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.