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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447991
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : November 4, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Robert W. Baloh, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Vestibular Migraine Migrainous Vertigo Drug: Rizatriptan Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
Drug Information available for: Rizatriptan

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Episodes With Complete Relief of Vertigo as Vestibular Symptom [ Time Frame: 1 hour after taking study medication ]
    The number of episodes in which complete relief of vertigo symptoms (rating 0) 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).

  2. Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms [ Time Frame: 1 hour after taking study medication ]
    The outcome was the number of episodes in which complete relief of symptoms of unsteadiness/dizziness (rating 0) 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).

  3. Episodes With Headache Reduced From Moderate/Severe to None/Mild [ Time Frame: 1 hour after taking study medication ]
    The outcome was the number of episodes in which a reduction of headache symptoms (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  4. Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild [ Time Frame: 1 hour after taking study medication ]
    The outcome was the number of episodes in which a reduction of symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  5. Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild [ Time Frame: 1 hour after taking study medication ]
    The outcome was the number of episodes in which a reduction of sensitivity to motion symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  6. Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild [ Time Frame: 1 hour after taking study medication ]
    The outcome was the number of episodes in which a reduction of symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  7. Satisfaction With Treatment [ Time Frame: 48 hour after taking study medication ]
    Treatment Satisfaction Questionnaire for Medication (TSQM) assessed four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).

  8. Health-Related Quality of Life [ Time Frame: 48 hour after taking study medication ]
    Short Form Survey - 12 (SF-12) assessed physical and mental well-being after taking study medication for each episode, generating composite scores in each domain from 12 questions. The range is 0-100 with higher scores indicated better physical and mental health functioning.

  9. Side Effects [ Time Frame: 48 hour after taking study medication ]
    Number of adverse events experienced by participants. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 categorizes all domains of physical and psychological side effects, grading them 1-mild, 2-moderate, 3-severe, 4-life threatening, 5-death.

  10. Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    Episodes in which participants achieved reduction of symptoms (from rating 2-3 to 0-1). After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  11. Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    Episodes in which participants achieved reduction of symptoms (from rating 2-3 to 0-1). After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  12. Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  13. Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  14. Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).

  15. Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication [ Time Frame: 24 hours after taking study medication ]
    After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms 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).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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


Locations
Layout table for location information
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
ICAHN School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Robert W. Baloh
Investigators
Layout table for investigator information
Principal Investigator: Robert W Baloh, M.D. University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Robert W. Baloh, University of California, Los Angeles:
Layout table for additonal 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    
Other Study ID Numbers: IRB12-001549
First Posted: May 19, 2015    Key Record Dates
Results First Posted: November 4, 2021
Last Update Posted: November 4, 2021
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Vertigo
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs