Rizatriptan for Episodic Dizziness in Vestibular Migraine

• ClinicalTrials.gov Identifier: NCT02447991
• Recruitment Status: Recruiting
• First Posted: May 19, 2015
• Last Update Posted: October 11, 2018
• 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)
• Estimated Enrollment: 200 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
• Study Start Date: December 2014
• Estimated Primary Completion Date: June 2019
• Estimated Study Completion Date: June 2019

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. 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 :

1. 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.

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

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

United States, New York

ICAHN School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

Contact: Joanna Jen, MD

Contact: Roxana Gonzalez 310-206-8511 grgonzalez@mednet.ucla.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 Posted: May 19, 2015
• Last Update Posted: October 11, 2018
• Last Verified: October 2018

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; Signs and Symptoms; Rizatriptan; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs