Rizatriptan for Episodic Dizziness in Vestibular Migraine

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Migraine; Migrainous Vertigo
• Intervention / Treatment: Drug: Placebo; Drug: Rizatriptan

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 Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Maxalt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication
Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes With Complete Relief of Vertigo as Vestibular Symptom	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).	1 hour after taking study medication
Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms	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).	1 hour after taking study medication
Episodes With Headache Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication
Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication
Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication
Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild	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).	1 hour after taking study medication
Satisfaction With Treatment	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).	48 hour after taking study medication
Health-Related Quality of Life	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.	48 hour after taking study medication
Side Effects	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.	48 hour after taking study medication
Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional 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).	24 hours after taking study medication
Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional 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).	24 hours after taking study medication
Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional 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).	24 hours after taking study medication
Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional 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).	24 hours after taking study medication
Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional 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).	24 hours after taking study medication
Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional 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).	24 hours after taking study medication

Collaborators and Investigators

• Sponsor: Robert W. Baloh
• Investigators: Principal Investigator: Robert W Baloh, M.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Headache Disorders, Primary; Headache Disorders; Vertigo; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Rizatriptan
• Other Study ID Numbers: IRB12-001549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No