Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
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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 |
- 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.
- 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.
- 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: | March 2014 |
| Estimated Primary Completion Date: | March 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:
|
|
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 |
Inclusion criteria
- Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
- All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
- Able to complete study assessments in person and by phone
- Able to travel to Mayo Clinic, Rochester, MN for first and last study visits
- Willing to avoid pregnancy during study (abstinence or acceptable birth control)
Exclusion criteria
- Presence of any other active neurotologic diagnoses
- Medical or psychiatric conditions that would preclude or confound study drugs
- Use of medications or supplements that would preclude or confound study drugs
- Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
- Allergy to verapamil or sertraline
Contacts and 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 | |
| Principal Investigator: | Jeffrey Staab, MD | Mayo Clinic |
More Information
Additional 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: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
migraine variant chronic dizziness |
Additional relevant MeSH terms:
|
Vestibular Diseases Dizziness Vertigo Migraine Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Verapamil Diltiazem Sertraline Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013