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

Meniere's Disease Clinical Trial

Official title:

Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01729767
• Other study ID #: 88-03-48-9453
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 14, 2012
• Last updated: November 19, 2012
• Start date: August 2011

Study information

• Verified date: November 2012
• Source: Tehran University of Medical Sciences
• Contact: Masoud Motesadi, MD.
• Phone: +982166760260
• Email: motesadi[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• Acyclovir
Patients who were randomly allocated to the Acyclovir group besides sticking with low salt diet will take the Acyclovir 400 mg pills 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 would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and their tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.
• Placebo
Participants who are randomly placed in placebo group, besides sticking with low salt diet will take the placebo (inert ingredient) 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 would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Amiralam Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertigo		Change from baseline after 3 months	Yes
Secondary	Hearing Loss	Method of measurement would be Audiometry and also subjective evaluation	Change from baseline after 3 months	Yes
Secondary	Aural Fullness	Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale	Change from baseline after 3 months	Yes
Secondary	Tinnitus	Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale	Change from baseline in 3 months	Yes