Clinical Trial of Antiviral Drugs for the Chronic Suppression of Meniere's Disease symptoms.
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
Professor William Gibson
80 participants
Apr 1, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Positive herpes serology (tested at the start of the trial)
- Positive transtympanic electrocochleography
- Clinical history of labial herpes infection
- Clinical history of cluster of attacks with periods of remission
Exclusion Criteria2
- Patients who have received treatment with gentamicin
- Patients who have had two or more vertigo attacks in the month prior to starting the intervention.
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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, 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).
Locations(1)
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ACTRN12612000053820