None listed
Conditions
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.
Interventions
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, an
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).
Sponsors
Professor William Gibson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
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.
Outcome results
None listed