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Completed

NCT Number: NCT02447991

Rizatriptan for Episodic Dizziness in Vestibular Migraine

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.

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Key information

Conditions

Vestibular Migraine Migrainous Vertigo

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rizatriptan

Drug

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

Other names: Maxalt

Placebo

Drug

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

Other names: Sugar Pill

Primary outcomes

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

    Time frame: 1 hour after taking study medication

    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).

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

    Time frame: 1 hour after taking study medication

    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 outcomes

  1. Episodes With Complete Relief of Vertigo as Vestibular Symptom

    Time frame: 1 hour after taking study medication

    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).

  2. Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms

    Time frame: 1 hour after taking study medication

    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).

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

    Time frame: 1 hour after taking study medication

    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).

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

    Time frame: 1 hour after taking study medication

    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).

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

    Time frame: 1 hour after taking study medication

    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).

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

    Time frame: 1 hour after taking study medication

    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).

  7. Satisfaction With Treatment

    Time frame: 48 hour after taking study medication

    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).

  8. Health-Related Quality of Life

    Time frame: 48 hour after taking study medication

    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.

  9. Side Effects

    Time frame: 48 hour after taking study medication

    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.

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

    Time frame: 24 hours after taking study 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).

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

    Time frame: 24 hours after taking study 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).

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

    Time frame: 24 hours after taking study 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).

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

    Time frame: 24 hours after taking study 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).

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

    Time frame: 24 hours after taking study 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).

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

    Time frame: 24 hours after taking study 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).

Sponsors and collaborators

Lead sponsor

Robert W. Baloh

Other

Registry information

Official study title

A Phase II/III Trial on Rizatriptan for Vestibular Migraine

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 19, 2015
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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