Rizatriptan for Episodic Dizziness in Vestibular Migraine

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-004558
    NCT ID: NCT02447991
    Sponsor Protocol Number: 12-001549

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Are between the ages of 18 & 65
  2. Have a history of vestibular migraine
  3. Are able to maintain a vestibular symptom diary
  4. History that fulfills all criteria for VM as defined in Table 1, except that attacks must last at least 2 hours.
  5. At least 5 episodes
  6. A current or past history of migraine without aura or migraine with aura
  7. Vestibular symptoms of moderate or severe intensity lasting at least 2 hours
  8. 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
  9. Experience photophobia and phonophobia
  10. Experience visual aura
  11. Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits.
  12. Other causes of vestibular symptoms ruled out by appropriate clinical investigations.
  13. Current medication list compatible with Concomitant Medications below.
  14. Able to maintain a Vestibular Symptom Diary and complete all other study procedures.

Exclusion Criteria:

  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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Staab, M.D.

Open for enrollment

Contact information:

Deanna Hofschulte CCRP

(507)255-2972

Hofschulte.Deanna@mayo.edu

.
CLS-20143942

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