Vestibular Migraine Clinical Trial
Official title:
A Pilot Trial of Galcanezumab for Vestibular Migraine
Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Male or female aged 18 to 75 years of age at Study Visit 1. 2. Documentation of a vestibular migraine or probable vestibular migraine diagnosis according to the following criteria determined by the Barany Society: - Vestibular migraine - A: At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours - B: Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD) - C: One or more migraine features with at least 50% of the vestibular episodes: - Headache with at least two of the following characteristics: one sided location, pulsating quality, moderate or severe pain intensity, aggravation by routine physical activity - Photophobia and phonophobia - Visual aura - D: Not better accounted for by another vestibular or ICHD diagnosis - Probable vestibular migraine - At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours - Only one of the criteria B and C for vestibular migraine is fulfilled (migraine history or migraine features during the episode) - Not better accounted for by another vestibular or ICHD diagnosis 3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 4. Baseline and Study Visit 2 VM-PATHI score > 25 5. Baseline (month 0 to 1) definite dizzy days > 4 6. Fluency in English 7. 80% adherence or better to daily text message during baseline phase 8. Written informed consent 9. Access to email, and cell phone Exclusion Criteria: 1. Pregnant, breastfeeding, or unwilling to use approved form of birth control during participation in the study. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 3. Allergy to galcanezumab 4. Prior treatment with galcanezumab 5. History of ear surgery (other than ear tubes) 6. Other vestibular diagnosis (excluding treated Benign Paroxysmal Positional Vertigo- BPPV). This includes Meniere's disease, superior canal dehiscence syndrome, vestibular neuritis, persistent postural perceptual dizziness, unilateral or bilateral vestibular loss, cerebellar or brainstem disease, multiple sclerosis, or Mal de Debarquement. 7. Failure of treatment with > 4 prophylactic migraine medications 8. Prior or current treatment with a CGRP medication 9. Pregnant/breastfeeding if female 10. History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, Raynaud's disease, uncontrolled psychiatric disease or past psychiatric hospitalization) 11. History of mania, psychosis, or suicidal ideations 12. Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start. |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Medical Center at Mount Zion | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Eli Lilly and Company |
United States,
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Mikulec AA, Faraji F, Kinsella LJ. Evaluation of the efficacy of caffeine cessation, nortriptyline, and topiramate therapy in vestibular migraine and complex dizziness of unknown etiology. Am J Otolaryngol. 2012 Jan-Feb;33(1):121-7. doi: 10.1016/j.amjoto.2011.04.010. Epub 2011 Jun 24. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score from Baseline to Month 4 | This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering. | Change between baseline (month 0) and after treatment (month 4) | |
Secondary | Change in Number of Definitive Dizzy Days for Participants Measured Daily from Baseline to Month 4 via Text Message | Participants will receive a daily text message to rate their dizziness from 0 (no dizziness), 1 (mild dizziness), 2 (moderate dizziness), and 3 (severe dizziness). A score of 2 or higher will count as a definitive dizzy day. | Change between baseline (month 0) and after treatment (month 4) | |
Secondary | Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days via Text Message from Baseline to Month 4 | Response rates will be measured by the percentage of participants in each arm experiencing a 100%, 75%, 50%, 25%, 0% reduction in definitive dizzy days. | Change between baseline (month 0) to after treatment (month 4) | |
Secondary | Change in Dizziness Handicap Inventory Score from Baseline to Month 4 | This is the most widely used measure of dizziness severity, and consists of 25 questions. Questions ask about problems related to dizziness, and are scored as no (0 points), sometimes (2 points), or always (4 points). Total score is between 0 and 100, with higher scores indicating more disability. | Change between baseline (month 0) to after treatment (month 4) | |
Secondary | Change in Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.2- Global Health Scores | There are 10 questions on this quality of life measure, each with a score of 1-5. Higher scores correspond to a greater extent of the concept measured (e.g., more fatigue). Two summed scores are generated, one for global mental health (question #3, 6, 7, 8) and one for global physical health (question #2, 4, 5, 10). The remaining 2 questions are analyzed separately.
Summed scores for physical health and mental health are converted into T-score values using the "HealthMeasures Scoring Service" available online. T-scores for physical health and mental health can be grouped into 5 categories based on the responses to question #1: "In general, would you say your health is excellent, very good, good, fair, or poor?" The cut points for each category is determined by calculating the midpoint between 2 adjacent means. For example, if the mean mental health T-score for "Excellent" is 61 and the mean T-score for "Very Good" is 51, then the cut point for these categories would be 56. |
Change between baseline (month 0) to after treatment (month 4) |
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