Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey P. Staab, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01669304
First received: August 14, 2012
Last updated: August 20, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Vestibular Migraine
Chronic Subjective Dizziness
Drug: Verapamil
Drug: Sertraline
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 2-week Average Rating of Severity of Headache from the Daily Symptom Diaries [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Daily ratings of headache will be evaluated at 2 week intervals for 12 weeks.

  • 2-week Average Rating of Severity of Dizziness/Unsteadiness from the Daily Symptom Diaries [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Daily ratings of dizziness/unsteadiness will be evaluated at 2 week intervals for 12 weeks.

  • 2-week Average Rating of Sensitivity to Motion of Self from the Daily Symptom Diaries [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Daily ratings of sensitivity to motion of self will be evaluated at 2 week intervals for 12 weeks.

  • 2-week Average Rating of Sensitivity to Motion in the Environment from the Daily Symptom Diaries [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Daily ratings of sensitivity to motion in the environment will be evaluated at 2 week intervals for 12 weeks.

  • 2-week Average Rating of Difficulty of Performing Precision Visual Tasks from the Daily Symptom Diaries [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Daily ratings of difficulty of performing precision visual tasks will be evaluated at 2 week intervals for 12 weeks.


Secondary Outcome Measures:
  • Mean Number of Acute Attacks Per Two Week Period [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Acute attacks will be assessed every 2 weeks for 12 weeks.

  • Mean Score of Dizziness Handicap Inventory (DHI) [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    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).

  • Mean Score of Migraine-Specific Quality of Life (MSQ) [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Mean score for Dizziness on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    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).

  • Mean score for Headache on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 32
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: October 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:
  • 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 Name: Zoloft

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669304

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Staab, MD Mayo Clinic
  More 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: August 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
migraine variant
chronic dizziness
pharmacologic dissection

Additional relevant MeSH terms:
Dizziness
Migraine Disorders
Vertigo
Brain Diseases
Central Nervous System Diseases
Ear Diseases
Headache Disorders
Headache Disorders, Primary
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases
Sertraline
Verapamil
Anti-Arrhythmia Agents
Antidepressive Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on August 27, 2015