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

Primary Purpose

Meniere's Disease

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Acyclovir
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amiralam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acyclovir

Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Vertigo

Secondary Outcome Measures

Hearing Loss
Method of measurement would be Audiometry and also subjective evaluation
Aural Fullness
Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
Tinnitus
Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale

Full Information

First Posted
November 14, 2012
Last Updated
November 19, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01729767
Brief Title
Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease
Official Title
Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acyclovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Other Intervention Name(s)
Zovirax
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pills, manufactured to mimic the Acyclovir 400 mg tablets.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vertigo
Time Frame
Change from baseline after 3 months
Secondary Outcome Measure Information:
Title
Hearing Loss
Description
Method of measurement would be Audiometry and also subjective evaluation
Time Frame
Change from baseline after 3 months
Title
Aural Fullness
Description
Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
Time Frame
Change from baseline after 3 months
Title
Tinnitus
Description
Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
Time Frame
Change from baseline in 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients' willingness to participate in the study Willingness to participate in follow ups Age of 18 or older Having at least 2 vertigos per month each lasting for at least 20 min, severely interfering with function Not on medication for at least 3 months before starting the trial Exclusion Criteria: History of Allergy to Acyclovir or the drugs in the same category Renal insufficiency or having Creatinine more than 1.5 mg/dl Hepatic enzymes more than 3 times normal Hematocrit less than 30% Thrombocytopenia Having a serious uncontrolled illness Pregnant or nursing ladies Using Probenecid Previous surgeries on Endolymphatic Sac.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Motesadi, MD.
Phone
+982166760260
Email
motesadi@sina.tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Parisa Mazaheri, MD.
Phone
703 638 8471
Email
mazaheri.parisa@gmail.com
Facility Information:
Facility Name
Amiralam Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Motesadi, MD.
Phone
+982166760260
Email
motesadi@sina.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Masoud Motesadi, MD.

12. IPD Sharing Statement

Learn more about this trial

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

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