Rizatriptan for Episodic Dizziness in Vestibular Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02447991|
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : February 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Migraine Migrainous Vertigo||Drug: Rizatriptan Drug: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II/III Trial on Rizatriptan for Vestibular Migraine|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Placebo Comparator: 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.
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
Other Name: Sugar Pill
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.
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
Other Name: Maxalt
- Proportion of treated vestibular migraine (VM) attacks in which subjects experience a reduction in severity rating [ Time Frame: Baseline, 1 hour after taking study medication ]After each attack subjects will complete an Acute Episode Rating form. Severity will be graded on a scale of 0 to 3, with 0 indicating " symptoms absent" and 3 indicating "severe symptoms"
- Treatment Satisfaction at 48 hours [ Time Frame: 48 hours after each attack treated with study medication ]Subjects will complete the Treatment Satisfaction Questionnaire for Medication (TSMQ) 48 hours after each attack treated with study medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447991
|Contact: Roxana Gonzalez||310-206-8511||GRGonzalez@mednet.ucla.edu|
|Contact: Deanna Hofschultefirstname.lastname@example.org|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Roxana G. Gonzalez 310-206-8511 GRGonzalez@mednet.ucla.edu|
|Contact: Robert W. Baloh, M.D. 310-206-8511 email@example.com|
|Principal Investigator: Robert W. Baloh, M.D.|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Deanna R Hofschulte 507-255-2972 firstname.lastname@example.org|
|Principal Investigator:||Robert W Baloh, M.D.||University of California, Los Angeles|