Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
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.
Chronic Subjective Dizziness
|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
|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)|
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.
Sertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness.
Other Name: Zoloft
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669304
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Jeffrey P Staab, MD 507-284-4159 firstname.lastname@example.org|
|Contact: Sherrie M Hanna 507-538-8341 email@example.com|
|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|