Trial record 5 of 6 for:    Open Studies | "Meniere Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01729767
First received: November 14, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Meniere's Disease
Drug: Acyclovir
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Vertigo [ Time Frame: Change from baseline after 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hearing Loss [ Time Frame: Change from baseline after 3 months ] [ Designated as safety issue: Yes ]
    Method of measurement would be Audiometry and also subjective evaluation

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

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


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729767

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

Locations
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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01729767     History of Changes
Other Study ID Numbers: 88-03-48-9453
Study First Received: November 14, 2012
Last Updated: November 19, 2012
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014