Rizatriptan for Episodic Dizziness in Vestibular Migraine
NCT ID: NCT02447991
Last Updated: 2021-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
223 participants
INTERVENTIONAL
2014-12-31
2020-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
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.
Placebo
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
Rizatriptan
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.
Rizatriptan
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rizatriptan
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
Placebo
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 attacks must 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
8. Experience photophobia and phonophobia
9. Experience visual aura
10. Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits.
11. Other causes of vestibular symptoms ruled out by appropriate clinical investigations.
12. Current medication list compatible with Concomitant Medications below.
13. Able to maintain a Vestibular Symptom Diary and complete all other study procedures.
Exclusion Criteria
2. Migraine with brainstem aura (formerly basilar-type migraine) by the International Classification 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Robert W. Baloh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert W. Baloh
Robert W. Baloh, M.D., UCLA Principal Investigator/Study Chair
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert W Baloh, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Los Angeles
Los Angeles, California, United States
Mayo Clinic
Rochester, Minnesota, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB12-001549
Identifier Type: -
Identifier Source: org_study_id