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Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

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ClinicalTrials.gov Identifier: NCT01669304
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey P. Staab, Mayo Clinic

August 14, 2012
August 21, 2012
August 24, 2015
August 2012
October 2014   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Daily Symptom Dairy [ Time Frame: baseline to 12 weeks ]
Daily ratings of headache and dizziness symptoms will be evaluated at 2 week intervals for 12 weeks.
Complete list of historical versions of study NCT01669304 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).
  • 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).
  • Migraine Disability Assessment (MIDAS) [ Time Frame: baseline to 12 weeks ]
    Headache related disability will be assessed every 2 weeks for 12 weeks.
  • Dizziness Handicap Inventory (DHI) [ Time Frame: baseline to 12 weeks ]
    Dizziness related handicap will be assessed every 4 weeks for 12 weeks.
  • Migraine-Specific Quality of Life (MSQ) [ Time Frame: baseline to 12 weeks ]
    Quality of life related to headache will be assessed at 4 weeks intervals for 12 weeks.
  • 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).
  • 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).
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline to 12 weeks ]
    Mood symptoms will be assessed at 2 week intervals for 12 weeks
  • Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: baseline to 12 weeks ]
    Anxiety symptoms will be assessed at 4 week intervals for 12 weeks
 
Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Vestibular Migraine
  • Chronic Subjective Dizziness
  • Drug: Verapamil
    Other Names:
    • Calan SR
    • Covera-HS
    • Isoptin SR
    • Verelan PM
  • Drug: Sertraline
    Other Name: Zoloft
  • 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.
    Intervention: Drug: Verapamil
  • 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.
    Intervention: Drug: Sertraline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
50
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01669304
12-002814
No
Not Provided
Not Provided
Jeffrey P. Staab, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Jeffrey Staab, MD Mayo Clinic
Mayo Clinic
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP