Galcanezumab for Vestibular Migraine (NCT04417361) | Clinical Trial Compass
CompletedPhase 2
Galcanezumab for Vestibular Migraine
United States40 participantsStarted 2020-09-18
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female aged 18 to 75 years of age at Study Visit 1.
✓. Documentation of a vestibular migraine or probable vestibular migraine diagnosis according to the following criteria determined by the Barany Society:
✓. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
✓. Baseline and Study Visit 2 VM-PATHI score \> 25
✓. Baseline (month 0 to 1) definite dizzy days \> 4
✓. Fluency in English
✓. 80% adherence or better to daily text message during baseline phase
✓. Written informed consent
Exclusion criteria
✕. Pregnant, breastfeeding, or unwilling to use approved form of birth control during participation in the study.
✕. 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.
What they're measuring
1
Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score From Baseline to Month 4
Timeframe: Change between baseline (month 1) and after treatment (month 4)
✕. History of ear surgery (other than ear tubes)
✕. 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.
✕. Failure of treatment with \> 4 prophylactic migraine medications
✕. Prior or current treatment with a CGRP medication