Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Phase 2

• Conditions: Meniere's Disease
• Interventions: Drug: Acyclovir; Drug: Placebo

• Registration Number: NCT01729767
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Meniere's disease is a chronic illness that affects a substantial number of patients every year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. It has recently been suggested that viral etiologies specially Herpes virus might be the underlying reason. The investigators study is a randomized, double- blinded placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease specially their vertigo attacks. Inclusion criteria would be patient's willingness to participate in the study and follow ups, being 18 years old or older, having at least 2 vertigos per month each at least 20 min, interfering with function, and not on medication for Meniere's disease for at least 3 months before the trial. They should not have any history of allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, 6 month intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-20
• Last Update Posted: 2012-11-20
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients' willingness to participate in the study
2. Willingness to participate in follow ups
3. Age of 18 or older
4. Having at least 2 vertigos per month each lasting for at least 20 min, severely interfering with function
5. Not on medication for at least 3 months before starting the trial

Exclusion Criteria

1. History of Allergy to Acyclovir or the drugs in the same category
2. Renal insufficiency or having Creatinine more than 1.5 mg/dl
3. Hepatic enzymes more than 3 times normal
4. Hematocrit less than 30%
5. Thrombocytopenia
6. Having a serious uncontrolled illness
7. Pregnant or nursing ladies
8. Using Probenecid
9. Previous surgeries on Endolymphatic Sac.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acyclovir	Acyclovir	Acyclovir 400 mg tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.
Placebo	Placebo	Placebo tablets by mouth 5 times a day for the first month, 3 times a day for next 10 days, and 2 times a day for the last 10 days.

Primary Outcome Measures

Name	Time	Method
Vertigo	Change from baseline after 3 months

Secondary Outcome Measures

Name	Time	Method
Hearing Loss	Change from baseline after 3 months	Method of measurement would be Audiometry and also subjective evaluation
Aural Fullness	Change from baseline after 3 months	Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
Tinnitus	Change from baseline in 3 months	Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale

Trial Locations

Locations (1)

Amiralam Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of