Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease
Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedNovember 20, 2012
November 1, 2012
1.3 years
November 14, 2012
November 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Vertigo
Change from baseline after 3 months
Secondary Outcomes (3)
Hearing Loss
Change from baseline after 3 months
Aural Fullness
Change from baseline after 3 months
Tinnitus
Change from baseline in 3 months
Study Arms (2)
Acyclovir
EXPERIMENTALAcyclovir 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 COMPARATORPlacebo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amiralam Hospital
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 20, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Last Updated
November 20, 2012
Record last verified: 2012-11