Clinical trial NCT02447991: Rizatriptan for Episodic Dizziness in Vestibular Migraine
Official title: A Phase II/III Trial on Rizatriptan for Vestibular Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vestibular Migraine
Migrainous Vertigo
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
measure: Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
Secondary outcomes:
measure: Episodes With Complete Relief of Vertigo as Vestibular Symptom
timeFrame: 1 hour after taking study medication
measure: Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms
timeFrame: 1 hour after taking study medication
measure: Episodes With Headache Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
measure: Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
measure: Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
measure: Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild
timeFrame: 1 hour after taking study medication
measure: Satisfaction With Treatment
timeFrame: 48 hour after taking study medication
measure: Health-Related Quality of Life
timeFrame: 48 hour after taking study medication
measure: Side Effects
timeFrame: 48 hour after taking study medication
measure: Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication
timeFrame: 24 hours after taking study medication
measure: Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication
timeFrame: 24 hours after taking study medication
measure: Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
timeFrame: 24 hours after taking study medication
measure: Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
timeFrame: 24 hours after taking study medication
measure: Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
timeFrame: 24 hours after taking study medication
measure: Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
timeFrame: 24 hours after taking study medication
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Robert W Baloh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: