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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01729767
Recruitment Status : Unknown
Verified November 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: Acyclovir Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital
Study Start Date : August 2011
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: Zovirax
Placebo Comparator: 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.
 Drug: 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.
Other Name: sugar pills, manufactured to mimic the Acyclovir 400 mg tablets.


Outcome Measures
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Primary Outcome Measures :
  1. Vertigo [ Time Frame: Change from baseline after 3 months ]

Secondary Outcome Measures :
  1. Hearing Loss [ Time Frame: Change from baseline after 3 months ]
    Method of measurement would be Audiometry and also subjective evaluation

  2. Aural Fullness [ Time Frame: Change from baseline after 3 months ]
    Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale

  3. Tinnitus [ Time Frame: Change from baseline in 3 months ]
    Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729767


Contacts
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Contact: Masoud Motesadi, MD. +982166760260 motesadi@sina.tums.ac.ir
Contact: Parisa Mazaheri, MD. 703 638 8471 mazaheri.parisa@gmail.com

Locations
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Iran, Islamic Republic of
Amiralam Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Masoud Motesadi, MD.    +982166760260    motesadi@sina.tums.ac.ir   
Principal Investigator: Masoud Motesadi, MD.         
Sponsors and Collaborators
Tehran University of Medical Sciences
More Information
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01729767    
Other Study ID Numbers: 88-03-48-9453
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Vertigo
Meniere Disease
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
 Neurologic Manifestations
Nervous System Diseases
Endolymphatic Hydrops
Acyclovir
Antiviral Agents
Anti-Infective Agents