Rizatriptan for Episodic Dizziness in Vestibular Migraine

Robert W. Baloh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vestibular Migraine; Migrainous Vertigo

Treatments: Drug: Rizatriptan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02447991

IRB12-001549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 223 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Rizatriptan

Experimental group

Description:

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.

Treatment:

Drug: Rizatriptan