Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline

Location:

Rochester, Minn., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:

2/11/2014

NCT ID:

NCT01669304

IRB Number:

12-002814