Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

August 20, 2015 updated by: Jeffrey P. Staab, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 was to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Subjects diagnosed with coexisting VM-CSD were treated with either verapamil or sertraline. It was hypothesized that a differential treatment response to these two pharmacologic probes would 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. It was hoped that the different mechanisms of action of the two study medications might also shed light on the physiologic underpinnings of VM and CSD.

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

A PD trial uses response to one or more pharmaceutical probes (drugs) to study physiologic mechanisms of illness. A PD trial may provide data to separate overlapping manifestations of comorbid illnesses. This is useful for conditions that lack biomarkers. It also may provide data to identify characteristics of illnesses (symptoms, signs, cellular processes) that are associated with specific pharmacologic mechanisms.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-week Average Rating of Severity of Headache from the Daily Symptom Diaries
Time Frame: Week 0 to Week 12
Daily ratings of headache will be evaluated at 2 week intervals for 12 weeks.
Week 0 to Week 12
2-week Average Rating of Severity of Dizziness/Unsteadiness from the Daily Symptom Diaries
Time Frame: Week 0 to Week 12
Daily ratings of dizziness/unsteadiness will be evaluated at 2 week intervals for 12 weeks.
Week 0 to Week 12
2-week Average Rating of Sensitivity to Motion of Self from the Daily Symptom Diaries
Time Frame: Week 0 to Week 12
Daily ratings of sensitivity to motion of self will be evaluated at 2 week intervals for 12 weeks.
Week 0 to Week 12
2-week Average Rating of Sensitivity to Motion in the Environment from the Daily Symptom Diaries
Time Frame: Week 0 to Week 12
Daily ratings of sensitivity to motion in the environment will be evaluated at 2 week intervals for 12 weeks.
Week 0 to Week 12
2-week Average Rating of Difficulty of Performing Precision Visual Tasks from the Daily Symptom Diaries
Time Frame: Week 0 to Week 12
Daily ratings of difficulty of performing precision visual tasks will be evaluated at 2 week intervals for 12 weeks.
Week 0 to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Acute Attacks Per Two Week Period
Time Frame: Week 0 to Week 12
Acute attacks will be assessed every 2 weeks for 12 weeks.
Week 0 to Week 12
Mean Score of Dizziness Handicap Inventory (DHI)
Time Frame: Week 0 to Week 12
Dizziness related handicap will be assessed every 4 weeks for 12 weeks. The Dizziness Handicap Inventory (DHI) consists of 25 questions, with a total possible score ranging from 0 (no dizziness) to 50 (severe dizziness).
Week 0 to Week 12
Mean Score of Migraine-Specific Quality of Life (MSQ)
Time Frame: Week 0 to Week 12
Quality of life related to headache will be assessed at 4 week intervals for 12 weeks. The Migraine-Specific Quality of Life 2.1 (MSQ) consists of 14 items, with a total possible score ranging from 14 (affected none of the time) to 84 (affected all of the time).
Week 0 to Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score for Dizziness on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)
Time Frame: Week 0 to Week 12
Dizziness symptoms will be assessed at 2 week intervals for 12 weeks. The Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) consists of 5 questions, with a total possible score ranging from 0 (no disability) to 72 (extremely disruptive).
Week 0 to Week 12
Mean score for Headache on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)
Time Frame: Week 0 to Week 12
Headache symptoms will be assessed at 2 week intervals for 12 weeks. The Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) consists of 5 questions, with a total possible score ranging from 0 (no disability) to 72 (extremely disruptive).
Week 0 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jeffrey Staab, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-002814

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vestibular Migraine

Clinical Trials on Sertraline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe