Rizatriptan for Episodic Dizziness in Vestibular Migraine

• 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: Robert W. Baloh
• Information provided by (Responsible Party): Robert W. Baloh, University of California, Los Angeles

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• 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:

Study Protocol and Statistical Analysis Plan  [PDF] June 22, 2018

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
• Other Study ID Numbers: IRB12-001549
• First Posted: May 19, 2015
• Results First Posted: November 4, 2021
• Last Update Posted: November 4, 2021
• Last Verified: October 2019

Additional relevant 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