Phase 3 N=134 Randomized Double-blind Treatment

Rizatriptan for Episodic Dizziness in Vestibular Migraine

Vestibular Migraine · Migrainous Vertigo

Bottom Line

View on ClinicalTrials.gov: NCT02447991 ↗

Enrolled (actual)

134

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild — 50; 73 Episodes — p=<0.33

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rizatriptan (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Robert W. Baloh
Primary completion: Jul 2020

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

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02447991). 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.