<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01729767</url>
  </required_header>
  <id_info>
    <org_study_id>88-03-48-9453</org_study_id>
    <nct_id>NCT01729767</nct_id>
  </id_info>
  <brief_title>Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease</brief_title>
  <official_title>Assessment of Acyclovir Efficacy Versus Placebo in Controlling Vertigo Attacks of Patients With Meniere's Disease Visited in Amiralam Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Meniere's disease is a chronic illness that affects a substantial number of patients every&#xD;
      year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from&#xD;
      minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure.&#xD;
      It has recently been suggested that viral etiologies specially Herpes virus might be the&#xD;
      underlying reason. The investigators study is a randomized, double- blinded&#xD;
      placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective&#xD;
      is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease&#xD;
      specially their vertigo attacks. Inclusion criteria would be patient's willingness to&#xD;
      participate in the study and follow ups, being 18 years old or older, having at least 2&#xD;
      vertigos per month each at least 20 min, interfering with function, and not on medication for&#xD;
      Meniere's disease for at least 3 months before the trial. They should not have any history of&#xD;
      allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more&#xD;
      than three times normal, serious uncontrolled illness, be pregnant or nursing or have&#xD;
      previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different&#xD;
      arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the&#xD;
      medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day&#xD;
      for the last 10 days. Patients will report changes in their symptoms 10 days after initiating&#xD;
      the drug and in 1, 3, 6 month intervals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vertigo</measure>
    <time_frame>Change from baseline after 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing Loss</measure>
    <time_frame>Change from baseline after 3 months</time_frame>
    <description>Method of measurement would be Audiometry and also subjective evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aural Fullness</measure>
    <time_frame>Change from baseline after 3 months</time_frame>
    <description>Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tinnitus</measure>
    <time_frame>Change from baseline in 3 months</time_frame>
    <description>Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Meniere's Disease</condition>
  <arm_group>
    <arm_group_label>Acyclovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acyclovir</intervention_name>
    <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.</description>
    <arm_group_label>Acyclovir</arm_group_label>
    <other_name>Zovirax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <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.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>sugar pills, manufactured to mimic the Acyclovir 400 mg tablets.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients' willingness to participate in the study&#xD;
&#xD;
          2. Willingness to participate in follow ups&#xD;
&#xD;
          3. Age of 18 or older&#xD;
&#xD;
          4. Having at least 2 vertigos per month each lasting for at least 20 min, severely&#xD;
             interfering with function&#xD;
&#xD;
          5. Not on medication for at least 3 months before starting the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of Allergy to Acyclovir or the drugs in the same category&#xD;
&#xD;
          2. Renal insufficiency or having Creatinine more than 1.5 mg/dl&#xD;
&#xD;
          3. Hepatic enzymes more than 3 times normal&#xD;
&#xD;
          4. Hematocrit less than 30%&#xD;
&#xD;
          5. Thrombocytopenia&#xD;
&#xD;
          6. Having a serious uncontrolled illness&#xD;
&#xD;
          7. Pregnant or nursing ladies&#xD;
&#xD;
          8. Using Probenecid&#xD;
&#xD;
          9. Previous surgeries on Endolymphatic Sac.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Masoud Motesadi, MD.</last_name>
    <phone>+982166760260</phone>
    <email>motesadi@sina.tums.ac.ir</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Parisa Mazaheri, MD.</last_name>
    <phone>703 638 8471</phone>
    <email>mazaheri.parisa@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amiralam Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Masoud Motesadi, MD.</last_name>
      <phone>+982166760260</phone>
      <email>motesadi@sina.tums.ac.ir</email>
    </contact>
    <investigator>
      <last_name>Masoud Motesadi, MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Meniere Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acyclovir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729767
org study id: 88-03-48-9453
nct id: NCT01729767
lead sponsor: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Vertigo
time frame: Change from baseline after 3 months
measure: Hearing Loss
time frame: Change from baseline after 3 months
description: Method of measurement would be Audiometry and also subjective evaluation
measure: Aural Fullness
time frame: Change from baseline after 3 months
description: Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
measure: Tinnitus
time frame: Change from baseline in 3 months
description: Method of measurement would be subjective evaluation in a 0 (with no symptom) to 4 (very severe) scale
arm group label: Acyclovir
arm group type: Experimental
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 group label: Placebo
arm group type: Placebo Comparator
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: Acyclovir
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.
arm group label: Acyclovir
other name: Zovirax
intervention type: Drug
intervention name: Placebo
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.
arm group label: Placebo
other name: sugar pills, manufactured to mimic the Acyclovir 400 mg tablets.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Masoud Motesadi, MD.
phone: +982166760260
email: motesadi@sina.tums.ac.ir
last name: Parisa Mazaheri, MD.
phone: 703 638 8471
email: mazaheri.parisa@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Meniere Disease
mesh term: Acyclovir