Not Yet RecruitingPhase 2ACTRN12612000053820

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


Sponsor

Professor William Gibson

Enrollment

80 participants

Start Date

Apr 1, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial tests whether antiviral drugs can reduce symptoms of Meniere's disease, a condition causing vertigo, hearing loss, and ringing in the ears. Participants aged 18 to 60 with confirmed Meniere's disease and positive herpes serology will receive antiviral medication to see if it prevents attacks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12612000053820


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