Phase 3
Completed N=134
Rizatriptan for Episodic Dizziness in Vestibular Migraine
vestibular migraine · Migrainous Vertigo
Source: ClinicalTrials.gov NCT02447991 ↗
Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild — 50; 73 Episodes — p=<0.33
◆ Published Evidence
Emerging
9citations · ~9 / year
Rizatriptan vs Placebo for Attacks of Vestibular Migraine: A Randomized Clinical Trial.
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.
Linked Publications
-
Rizatriptan vs Placebo for Attacks of Vestibular Migraine: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild |
50; 73 | <0.33 |
| PRIMARY Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild |
11; 29 | <0.18 |
| SECONDARY Episodes With Complete Relief of Vertigo as Vestibular Symptom |
35; 56 | <0.62 |
| SECONDARY Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms |
2; 12 | <0.19 |
| SECONDARY Episodes With Headache Reduced From Moderate/Severe to None/Mild |
38; 44 | <0.14 |
| SECONDARY Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild |
33; 59 | <0.72 |
| SECONDARY Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild |
19; 39 | <0.48 |
| SECONDARY Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild |
50; 67 | <0.35 |
| SECONDARY Satisfaction With Treatment |
37.2; 49.7; 78.8; 81.6; 70.0; 71.0 | <0.022 sig |
| SECONDARY Health-Related Quality of Life |
37.5; 41.9; 44.2; 45.4 | <0.009 sig |
| SECONDARY Side Effects |
7; 44; 11; 51; 8; 19 | <0.013 sig |
| SECONDARY Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication |
54; 97 | <0.76 |
| SECONDARY Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication |
41; 90 | <0.041 sig |
| SECONDARY Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication |
46; 94 | <0.12 |
| SECONDARY Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication |
45; 95 | <0.051 |
| SECONDARY Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication |
42; 95 | <0.006 sig |
| SECONDARY Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication |
57; 101 | <0.67 |
Eligibility Criteria
Inclusion Criteria: Must answer yes to be eligible
- Are between the ages of 18 & 65
- Have a history of vestibular migraine
- 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.
- At least 5 episodes
- A current or past history of migraine without aura or migraine with aura
- Vestibular symptoms of moderate or severe intensity lasting at least 2 hours
- 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
- Experience photophobia and phonophobia
- Experience visual aura
- Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits.
- Other causes of vestibular symptoms ruled out by appropriate clinical investigations.
- Current medication list compatible with Concomitant Medications below.
- Able to maintain a Vestibular Symptom Diary and complete all other study procedures.
Exclusion Criteria: Must answer no to be eligible.
- Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) criteria60.
- Migraine with brainstem aura (formerly basilar-type migraine) by the International Classification of Headache Disorders (ICHD-3) criteria.14
- Ischemic heart disease, coronary artery vasospasm, uncontrolled hypertension.
- History of stroke or transient ischemic attack.
- History of using rizatriptan specifically to treat vestibular attacks.
- History of adverse response to triptans or intolerance to lactose.
- Women who are pregnant or breastfeeding.
- Unable or unwilling to comply with study requirements for any reason.
Data sourced from ClinicalTrials.gov (NCT02447991) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.