A Phase II/III Trial on Rizatriptan for Vestibular Migraine
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Vestibular Migraine
- Sponsor
- Robert W. Baloh
- Enrollment
- 223
- Locations
- 3
- Primary Endpoint
- Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Robert W. Baloh
Robert W. Baloh, M.D., UCLA Principal Investigator/Study Chair
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Must answer yes to be eligible
- •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
- •50% of episodes are associated with at least one of the following:
- •Headache with at least 2 of:
Exclusion Criteria
- •Must answer no to be eligible.
- •Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) criteria
- •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.
Arms & Interventions
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.
Intervention: Placebo
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.
Intervention: Rizatriptan
Outcomes
Primary Outcomes
Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
Time Frame: 1 hour after taking study medication
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).
Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild
Time Frame: 1 hour after taking study medication
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).
Secondary Outcomes
- Episodes With Complete Relief of Vertigo as Vestibular Symptom(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 Nausea/Vomiting Reduced From Moderate/Severe to None/Mild(1 hour after taking study medication)
- Satisfaction With Treatment(48 hour after taking study medication)
- Health-Related Quality of Life(48 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 Sensitivity to Motion Reduced From Moderate/Severe to None/Mild(1 hour after taking study medication)
- Side Effects(48 hour after taking study medication)
- Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication(24 hours after taking study medication)
- Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication(24 hours after taking study medication)
- Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication(24 hours after taking study medication)
- Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication(24 hours after taking study medication)
- Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication(24 hours after taking study medication)
- Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication(24 hours after taking study medication)