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Rizatriptan for Episodic Dizziness in Vestibular Migraine

This study is currently recruiting participants.
Verified October 2016 by Robert W. Baloh, University of California, Los Angeles
Sponsor:
ClinicalTrials.gov Identifier:
NCT02447991
First Posted: May 19, 2015
Last Update Posted: October 26, 2016
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.
Information provided by (Responsible Party):
Robert W. Baloh, University of California, Los Angeles
  Purpose

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 Intervention Phase
Vestibular Migraine Migrainous Vertigo Drug: Rizatriptan Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II/III Trial on Rizatriptan for Vestibular Migraine

Resource links provided by NLM:


Further study details as provided by Robert W. Baloh, University of California, Los Angeles:

Primary Outcome Measures:
  • 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"


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: December 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
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
Experimental: 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.
Drug: Rizatriptan
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
Other Name: Maxalt

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Roxana Gonzalez 310-206-8511 GRGonzalez@mednet.ucla.edu
Contact: Deanna Hofschulte 507-255-2972 hofschulte.deanna@mayo.edu

Locations
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    rwbaloh@ucla.edu   
Principal Investigator: Robert W. Baloh, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Deanna R Hofschulte    507-255-2972    hofschulte.deanna@mayo.edu   
Sponsors and Collaborators
Robert W. Baloh
Investigators
Principal Investigator: Robert W Baloh, M.D. University of California, Los Angeles
  More Information

Responsible Party: Robert W. Baloh, Robert W. Baloh, M.D., UCLA Principal Investigator/Study Chair, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02447991     History of Changes
Other Study ID Numbers: IRB12-001549
First Submitted: March 18, 2015
First Posted: May 19, 2015
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Migraine Disorders
Vertigo
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Signs and Symptoms
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs