Rizatriptan for Episodic Dizziness in Vestibular Migraine

NCT02447991 | Completed Phase 2 Results DMC

• 1 other identifier: IRB12-001549
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Vestibular Migraine; Migrainous Vertigo

Outcome Measures

Primary Outcomes (2)

• Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild

  Episodes in which a reduction in symptom severity from moderate/severe (rating 2/3) at time of taking study medication to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

  1 hour after taking study medication

• Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild

  Episodes of unsteadiness/dizziness in which a reduction in symptom severity from moderate/severe (rating 2/3) to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

  1 hour after taking study medication

Secondary Outcomes (15)

• Episodes With Complete Relief of Vertigo as Vestibular Symptom

  1 hour after taking study medication

• Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms

  1 hour after taking study medication

• Episodes With Headache Reduced From Moderate/Severe to None/Mild

  1 hour after taking study medication

• Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild

  1 hour after taking study medication

• Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild

  1 hour after taking study medication

Study Arms (2)

Placebo

PLACEBO COMPARATOR

During the Treatment Phase, three placebo capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.

Drug: Placebo

Rizatriptan

EXPERIMENTAL

During the Treatment Phase, three Rizatriptan capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug.

Drug: Rizatriptan

Interventions

Rizatriptan DRUG

During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.

Also known as: Maxalt

Rizatriptan

Placebo DRUG

During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Are between the ages of 18 \& 65
• Have a history of vestibular migraine
• Are able to maintain a vestibular symptom diary
• History that fulfills all criteria for VM as defined in Table 1, except that attacks must last at least 2 hours.
• At least 5 episodes
• A current or past history of migraine without aura or migraine with aura
• Vestibular symptoms of moderate or severe intensity lasting at least 2 hours
• % 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
• Experience photophobia and phonophobia
• Experience visual aura

You may not qualify if:

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

Sponsors & Collaborators

• Robert W. Baloh: lead

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Staab JP, Eggers SDZ, Jen JC, LeMahieu AM, Geske JR, Liu H, Hofschulte DR, Gonzalez GR, Neff BA, Shepard NT, McCaslin DL, Baloh RW. Rizatriptan vs Placebo for Attacks of Vestibular Migraine: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):676-686. doi: 10.1001/jamaneurol.2025.1006.

  PMID: 40354049 DERIVED

MeSH Terms

Interventions

rizatriptan; Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Jeffrey Staab, MD
• Organization: Mayo Clnic

staab.jeffrey@mayo.edu

507-293-9438

Study Officials

• Robert W Baloh, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Robert W. Baloh, M.D., UCLA Principal Investigator/Study Chair

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: May 19, 2015
• Study Start: December 1, 2014
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2019-10

Locations

US (3)