Rizatriptan for Episodic Dizziness in Vestibular Migraine
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/13/2018 |
| Start Date: | December 2014 |
| End Date: | June 2019 |
| Contact: | Roxana Gonzalez |
| Email: | GRGonzalez@mednet.ucla.edu |
| Phone: | 310-206-8511 |
A Phase II/III Trial on Rizatriptan for Vestibular Migraine
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.
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.
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.
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.
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 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: Must answer no to be eligible.
1. Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery
Foundation (AAO-HNS) criteria60.
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.
We found this trial at
3
sites
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Robert W. Baloh, M.D.
Phone: 310-206-8511
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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