Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

NCT01669304 | Completed Phase 1

• 1 other identifier: 12-002814
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vestibular Migraine; Chronic Subjective Dizziness

Keywords

migraine variant; chronic dizziness; pharmacologic dissection

Outcome Measures

Primary Outcomes (5)

• 2-week Average Rating of Severity of Headache from the Daily Symptom Diaries

  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

  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

  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

  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

  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 Outcomes (3)

• Mean Number of Acute Attacks Per Two Week Period

  Week 0 to Week 12

• Mean Score of Dizziness Handicap Inventory (DHI)

  Week 0 to Week 12

• Mean Score of Migraine-Specific Quality of Life (MSQ)

  Week 0 to Week 12

Other Outcomes (2)

• Mean score for Dizziness on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)

  Week 0 to Week 12

• Mean score for Headache on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)

  Week 0 to Week 12

Study Arms (2)

Verapamil

EXPERIMENTAL

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

Sertraline

EXPERIMENTAL

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

Interventions

Verapamil DRUG

Also known as: Calan SR, Covera-HS, Isoptin SR, Verelan PM

Verapamil

Sertraline DRUG

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
• All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
• Able to complete study assessments in person and by phone
• Able to travel to Mayo Clinic, Rochester, Minnesota for first and last study visits
• Willing to avoid pregnancy during study (abstinence or acceptable birth control)

You may not qualify if:

• Presence of any other active neurotologic diagnoses
• Medical or psychiatric conditions that would preclude or confound study drugs
• Use of medications or supplements that would preclude or confound study drugs
• Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
• Allergy to verapamil or sertraline

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Staab JP, Ruckenstein MJ. Expanding the differential diagnosis of chronic dizziness. Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):170-6. doi: 10.1001/archotol.133.2.170.

  PMID: 17309987 BACKGROUND

• Ruckenstein MJ, Staab JP. Chronic subjective dizziness. Otolaryngol Clin North Am. 2009 Feb;42(1):71-7, ix. doi: 10.1016/j.otc.2008.09.011.

  PMID: 19134491 BACKGROUND

• Eggers SD, Staab JP, Neff BA, Goulson AM, Carlson ML, Shepard NT. Investigation of the coherence of definite and probable vestibular migraine as distinct clinical entities. Otol Neurotol. 2011 Sep;32(7):1144-51. doi: 10.1097/MAO.0b013e31822a1c67.

  PMID: 21799457 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Verapamil; Sertraline

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jeffrey Staab, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 21, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

US (1)