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Rizatriptan for Episodic Dizziness in Vestibular Migraine

Primary Purpose

Vestibular Migraine, Migrainous Vertigo

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rizatriptan

Placebo

About this trial

This is an interventional treatment trial for Vestibular Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, Los Angeles
Mayo Clinic
ICAHN School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Rizatriptan

Arm 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.

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.

Outcomes

Primary Outcome Measures

Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild

Episodes in which a reduction in symptom severity from moderate/severe (rating 2/3) at time of taking study medication to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild

Episodes of unsteadiness/dizziness in which a reduction in symptom severity from moderate/severe (rating 2/3) to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Secondary Outcome Measures

Episodes With Complete Relief of Vertigo as Vestibular Symptom

The number of episodes in which complete relief of vertigo symptoms (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms

The outcome was the number of episodes in which complete relief of symptoms of unsteadiness/dizziness (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Headache Reduced From Moderate/Severe to None/Mild

The outcome was the number of episodes in which a reduction of headache symptoms (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild

The outcome was the number of episodes in which a reduction of symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild

The outcome was the number of episodes in which a reduction of sensitivity to motion symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild

Satisfaction With Treatment

Treatment Satisfaction Questionnaire for Medication (TSQM) assessed four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).

Health-Related Quality of Life

Short Form Survey - 12 (SF-12) assessed physical and mental well-being after taking study medication for each episode, generating composite scores in each domain from 12 questions. The range is 0-100 with higher scores indicated better physical and mental health functioning.

Side Effects

Number of adverse events experienced by participants. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 categorizes all domains of physical and psychological side effects, grading them 1-mild, 2-moderate, 3-severe, 4-life threatening, 5-death.

Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication

Episodes in which participants achieved reduction of symptoms (from rating 2-3 to 0-1). After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication

Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication

After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).

Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication

Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication

Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication

Full Information

NCT ID

NCT02447991

First Posted

March 18, 2015

Last Updated

October 6, 2021

Sponsor

Robert W. Baloh

1. Study Identification

Unique Protocol Identification Number

NCT02447991

Brief Title

Rizatriptan for Episodic Dizziness in Vestibular Migraine

Official Title

A Phase II/III Trial on Rizatriptan for Vestibular Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Robert W. Baloh

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Migraine, Migrainous Vertigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

223 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

Rizatriptan

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Rizatriptan

Other Intervention Name(s)

Maxalt

Intervention Description

During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.

Primary Outcome Measure Information:

Title

Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild

Description

Time Frame