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Trial registered on ANZCTR


Registration number
ACTRN12612000053820
Ethics application status
Not yet submitted
Date submitted
10/01/2012
Date registered
11/01/2012
Date last updated
11/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Trial of Antiviral Drugs for the Chronic Suppression of Meniere's Disease symptoms.
Scientific title
A Phase II, double-blind, placebo-controlled clinical trial of long term (up to 9 month) daily treatment with two 500mg Valtrex (Valaciclovir) tablets for the chronic suppression of recurrences of Meniere's Disease symptoms in participants with a positive herpes serology
Secondary ID [1] 279702 0
Nil
Universal Trial Number (UTN)
U1111-1127-0038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniere's Disease 285535 0
Herpes Infection 285540 0
Condition category
Condition code
Ear 285726 285726 0 0
Other ear disorders
Infection 285727 285727 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will involve patients diagnosed with Meniere's Disease with a positive herpes serology. Participants will be required to take two Valtrex tablets per day, with each tablet containing 500 mg of Valaciclovir (trade name Valtrex). Participants will continue taking tablets on a regular daily basis for 9 months or until further intervention. The end-point of the treatment occurs either at the end of 9 months, or when the participant withdraws from the trial.
During the treatment period, and for a subsequent 3 months follow-up, participants will be asked to maintain a daily diary of their wellbeing, vertigo and hearing (each with a 0-5 rating scale).
Intervention code [1] 283996 0
Treatment: Drugs
Comparator / control treatment
Participants will blindly be given either a supply of the active drug (Valtrex tablet) or a placebo tablet (control).
Control group
Placebo

Outcomes
Primary outcome [1] 286253 0
The primary outcome measure will be the frequency of vertigo attacks during the trial, with vertigo being defined as both a perceived nystagmus and the sensation of vertigo lasting longer than 20 minutes. Vertigo attacks will be recorded by the participant in a daily diary with a rating scale of 0 (no balance problems) to 5 (perceived nystagmus with dizziness lasting longer than 20 minutes).
Timepoint [1] 286253 0
At 9 months after the commencement of the intervention.
Secondary outcome [1] 295449 0
The level of subjective hearing fluctuation. Participants will log their subjective hearing function in a daily diary using a rating scale of (compared to previous day)
0 - no hearing change
1 - hearing loss
2 - hearing improvement
3 - increased tinnitus annoyance
4 - decreased tinnitus annoyance
5 - unsure about change
(multiple numbers can be chosen)
Timepoint [1] 295449 0
At 9 months after the commencement of the intervention.
Secondary outcome [2] 295450 0
The subjective level of tinnitus, which will be derived from the hearing fluctuation rating scale logged in the participant daily diary (above).
Timepoint [2] 295450 0
At 9 months after the commencement of the intervention.
Secondary outcome [3] 295452 0
The subjective level of wellbeing will be logged by the participant in the daily diary using a rating scale of 0 - not stressed to 5 - extremely stressed.
Timepoint [3] 295452 0
At 9 months after the commencement of the intervention.
Secondary outcome [4] 295454 0
Comparison of the time until the first vertigo attack within the 9 month treatment period. The vertigo attack timing will be derived from the participant's daily diary, and the vertigo rating scale of 0-5 (with 5 being a true vertigo attack with nystagmus and dizziness lasting longer than 20 minutes).
Timepoint [4] 295454 0
At 9 months after the commencement of the intervention.

Eligibility
Key inclusion criteria
Subjects will be chosen who have definite Meniere's Disease according to the AAO-HNS criteria. They will also fulfil the following inclusion criteria:
1) Positive herpes serology (tested at the start of the trial)
2) Positive transtympanic electrocochleography
3) Clinical history of labial herpes infection
4) Clinical history of cluster of attacks with periods of remission
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients who have received treatment with gentamicin
2) Patients who have had two or more vertigo attacks in the month prior to starting the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Meniere's Disease sufferers will be asked to participate during routine clinical visits, or approached to participate via two magazine publications produced in Australia for Meniere's Sufferers. Participants will be asked to enroll by the Principal Researcher, who is the clinician responsible for the initial diagnosis and assessment of the efficacy of the trial treatment (used to determine the outcome). After the initial diagnosis, the participant is then sent to a Secondary Researcher at a nearby facility (<300m away). The Secondary Researcher will be responsible for randomly allocating each patient a supply of the active or placebo tablets. Tablets will be de-identified. The Secondary Researcher is the only person who will know what each participant is taking until the end-point for each participant. The Secondary Researcher will maintain a private log of each participant's name and the drug allocated to them.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Secondary Researcher will use a "covariate-adaptive randomization" method to approximately randomize the allocation of drugs between the active and placebo groups. Covariates will include the number of participants assigned to each group, age, sex and severity of the disease (based on the AAO-HNS criteria for assessing Meniere's severity).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284485 0
University
Name [1] 284485 0
The Sydney Medical Foundation Meniere's Research Fund
Country [1] 284485 0
Australia
Primary sponsor type
Individual
Name
Professor William Gibson
Address
155 Missenden Rd.
Suite 7 The Chancellory Building, Newtown
Sydney NSW 2050.
Country
Australia
Secondary sponsor category [1] 283409 0
Individual
Name [1] 283409 0
Dr Daniel Brown
Address [1] 283409 0
100 Mallett Street.
Room 507, Brain & Mind Research Inst., Camperdown
Sydney NSW 2050
Country [1] 283409 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286467 0
Sydney South West Area Health Service
Ethics committee address [1] 286467 0
Research and Ethics Office
Locked Bag 7017
LIVERPOOL BC NSW 1871
Ethics committee country [1] 286467 0
Australia
Date submitted for ethics approval [1] 286467 0
19/02/2012
Approval date [1] 286467 0
Ethics approval number [1] 286467 0

Summary
Brief summary
Meniere's Disease is characterized by unpredictable attacks of debilitating vertigo, interspersed with periods of quiescence. It affects around 50,000 Australians. Several studies have provided supportive evidence that a viral infection of the inner ear may be the cause of the disease, but few studies have trialled antivirals as a preventative treatment. This trial will involve a double-blind, placebo-controlled clinical trial to evaluate the effectiveness of preventing the vertigo attacks in Meniere's Disease with antiviral drugs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33613 0
Address 33613 0
Country 33613 0
Phone 33613 0
Fax 33613 0
Email 33613 0
Contact person for public queries
Name 16860 0
Dr Daniel Brown
Address 16860 0
100 Mallett Street
room 507, Brain & Mind Research Inst., Camperdown
Sydney NSW 2050
Country 16860 0
Australia
Phone 16860 0
+61 2 93510748
Fax 16860 0
+61 2 9351 0855
Email 16860 0
[email protected]
Contact person for scientific queries
Name 7788 0
Professor William Gibson
Address 7788 0
155 Missenden Rd.
Suite 7 The Chancellory Building, Newtown
Sydney NSW 2050.
Country 7788 0
Australia
Phone 7788 0
+61 2 95191489
Fax 7788 0
+61 2 95191454
Email 7788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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