NCT02447991

Rizatriptan for Episodic Dizziness in Vestibular Migraine

A Phase II/III Trial on Rizatriptan for Vestibular Migraine

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Robert W. Baloh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vestibular Migraine
• Migrainous Vertigo

Interventions

Type	Name	Description
DRUG	Rizatriptan	During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
DRUG	Placebo	During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2015-05-19
• Last updated: 2021-11-04
• Results posted: 2021-11-04

Locations

3 sites across 1 country: United States