Vestibular Migraine |
Vestibular Migraine research study
What is the primary objective of this study?
Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo, unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand them better. VM and CSD occur together in about 1/3 of patients. That makes it hard to diagnose them accurately and decide what treatments to use. As a result, doctors and patients may be confused about these diagnoses. The goal of this study was use two different medications to tease apart the symptoms of VM and CSD. Patients who have VM and CSD together were given either verapamil or sertraline for 12 weeks. These medications are used to treat VM and CSD, though they are not approved for this purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is believed to have stronger effects on symptoms of CSD. By comparing the responses of patients to these two medications, the researchers hoped to learn more about the key features 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, Minnesota 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Subjective Dizziness
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
VerapamilVerapamil 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.
SertralineSertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness.
Start Date: August 2012
Completed Date: October 2014
Phase: Phase 1
Primary Outcome: 2-week Average Rating of Severity of Headache from the Daily Symptom Diaries
Secondary Outcome: Mean Number of Acute Attacks Per Two Week Period
Study sponsors, principal investigator, and references
Principal Investigator: Jeffrey Staab, MD
Lead Sponsor: Mayo Clinic
Staab JP, Ruckenstein MJ. Expanding the differential diagnosis of chronic dizziness. Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):170-6.