Rizatriptan for Episodic Dizziness in Vestibular Migraine

Last updated: October 6, 2021
Sponsor: Robert W. Baloh
Overall Status: Completed

Phase

2/3

Condition

Migraine And Cluster Headaches

Migraine (Adult)

Vestibular Hypofunction

Treatment

N/A

Clinical Study ID

NCT02447991
IRB12-001549
  • Ages 18-65
  • All Genders

Study Summary

Suffering from dizzy spells and migraine headaches?

Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.

University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to participate in a research study. The purpose of this study is to look at the natural history of VM and learn more about common symptoms. Investigators also want to learn the effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used for spells of dizziness in people with VM.

Patients may be eligible to participate if:

  • Patients are between the ages of 18 & 65

  • Patients have a history of vestibular migraine

  • Patients are able to maintain a vestibular symptom diary

The study includes 3 visits with compensation. All participants must complete questionnaires on dizziness, headache symptoms, general health and well-being, mental health, and a questionnaire on patient's satisfaction with study medication.

Eligibility Criteria

Inclusion

Inclusion Criteria: Must answer yes to be eligible

  1. Are between the ages of 18 & 65
  2. Have a history of vestibular migraine
  3. Are able to maintain a vestibular symptom diary History that fulfills all criteria for VM as defined in Table 1, except that attacksmust last at least 2 hours.
  4. At least 5 episodes
  5. A current or past history of migraine without aura or migraine with aura
  6. Vestibular symptoms of moderate or severe intensity lasting at least 2 hours
  7. 50% of episodes are associated with at least one of the following: Headache with at least 2 of:
  • unilateral location
  • pulsating quality
  • moderate or severe intensity,
  • aggravation by routine physical activity
  1. Experience photophobia and phonophobia
  2. Experience visual aura
  3. Episodes must have a spontaneous onset and resolution without associated hearing lossor interictal neurotologic deficits.
  4. Other causes of vestibular symptoms ruled out by appropriate clinical investigations.
  5. Current medication list compatible with Concomitant Medications below.
  6. Able to maintain a Vestibular Symptom Diary and complete all other study procedures.

Exclusion

Exclusion Criteria: Must answer no to be eligible.

  1. Ménière's disease by The American Academy of Otolaryngology-Head and Neck SurgeryFoundation (AAO-HNS) criteria60.
  2. Migraine with brainstem aura (formerly basilar-type migraine) by the InternationalClassification of Headache Disorders (ICHD-3) criteria.14
  3. Ischemic heart disease, coronary artery vasospasm, uncontrolled hypertension.
  4. History of stroke or transient ischemic attack.
  5. History of using rizatriptan specifically to treat vestibular attacks.
  6. History of adverse response to triptans or intolerance to lactose.
  7. Women who are pregnant or breastfeeding.
  8. Unable or unwilling to comply with study requirements for any reason.

Study Design

Total Participants: 223
Study Start date:
December 01, 2014
Estimated Completion Date:
July 31, 2020

Study Description

The primary Specific Aim is to conduct the first successful controlled study of a treatment for Vestibular Migraine. The investigators hypothesize that rizatriptan will be superior to a look alike inactive capsule for:

1a. Reducing the severity and duration of vertigo attacks in patients with Vestibular Migraine,

1b. Reducing the severity of symptoms commonly associated with vertigo attacks in patients with Vestibular Migraine (e.g., nausea, vomiting, motion sensitivity, gait disturbance, headache, light and sound sensitivity), and

1c. Improving treatment satisfaction and health-related quality of life in patients with Vestibular Migraine, and that

1d. Rizatriptan will be well tolerated by patients with Vestibular Migraine.

Connect with a study center

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • ICAHN School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

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