Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Jeffrey P. Staab, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01669304
First received: August 14, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.

The primary goal of this study to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Fifty patients diagnosed with coexisting VM-CSD will be treated with either verapamil or sertraline. Based on clinical and research experience to date, verapamil is thought to have greater effect on migraine-related symptoms, whereas sertraline is thought to have greater effect on CSD-related symptoms. It is hypothesized that a differential treatment response to these two pharmacologic probes will help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. The different mechanisms of action of the two study medications may also shed light on the physiologic underpinnings of VM and CSD.

This project will be a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection trial. A 12-week treatment period will follow 2 weeks of baseline observation. Patients will chart daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression will be measured at two week intervals. Data will be analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.


Condition Intervention Phase
Vestibular Migraine
Chronic Subjective Dizziness
Drug: Verapamil
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in severity of headache and dizziness in Daily Symptom Dairy [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Daily ratings of headache and dizziness symptoms will be evaluated at 2 week intervals for 12 weeks.


Secondary Outcome Measures:
  • Change in score of Migraine Disability Assessment (MIDAS) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Headache related disability will be assessed every 2 weeks for 12 weeks.

  • Change in score of Dizziness Handicap Inventory (DHI) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Dizziness related handicap will be assessed every 4 weeks for 12 weeks.

  • Change in score of Migraine-Specific Quality of Life (MSQ) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Quality of life related to headache will be assessed at 4 weeks intervals for 12 weeks.


Other Outcome Measures:
  • Change in score of Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: Yes ]
    Mood symptoms will be assessed at 2 week intervals for 12 weeks

  • Change in score of Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Anxiety symptoms will be assessed at 4 week intervals for 12 weeks


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verapamil
Verapamil extended release oral tablets administered in a flexible dose format ranging from 120 mg to 360 mg daily, as determined by severity of headache and dizziness.
Drug: Verapamil
Other Names:
  • Calan SR
  • Covera-HS
  • Isoptin SR
  • Verelan PM
Experimental: Sertraline
Sertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness.
Drug: Sertraline
Other Name: Zoloft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
  2. All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
  3. Able to complete study assessments in person and by phone
  4. Able to travel to Mayo Clinic, Rochester, MN for first and last study visits
  5. Willing to avoid pregnancy during study (abstinence or acceptable birth control)

Exclusion criteria

  1. Presence of any other active neurotologic diagnoses
  2. Medical or psychiatric conditions that would preclude or confound study drugs
  3. Use of medications or supplements that would preclude or confound study drugs
  4. Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
  5. Allergy to verapamil or sertraline
  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: NCT01669304

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jeffrey P Staab, MD    507-284-4159    staab.jeffrey@mayo.edu   
Contact: Sherrie M Hanna    507-538-8341    hanna.sherrie@mayo.edu   
Sub-Investigator: Scott D Eggers, MD         
Sub-Investigator: Brian A Neff, MD         
Sub-Investigator: Neil T Shepard, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Staab, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Jeffrey P. Staab, Associate Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01669304     History of Changes
Other Study ID Numbers: 12-002814
Study First Received: August 14, 2012
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
migraine variant
chronic dizziness

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Dizziness
Migraine Disorders
Vertigo
Brain Diseases
Central Nervous System Diseases
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases
Sertraline
Verapamil
Anti-Arrhythmia Agents
Antidepressive Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on October 23, 2014