Galcanezumab Is Effective in Vestibular Migraine Treatment

Researchers conducted a single-site, prospective, double-blind, placebo-controlled randomized clinical trial (INVESTMENT trial; ClinicalTrials.gov Identifier: NCT04417361) between October 2020 and March 2023 to determine whether galcanezumab effectively treats vestibular migraine. Adults aged 18 to 75 who were fluent in English, had access to a cell phone and email, and had a diagnosis of vestibular migraine or probable vestibular migraine were eligible for inclusion. Patients were randomly assigned 1:1 to receive either galcanezumab or placebo for 3 months. The primary outcome was change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) score from baseline to month 4. Bivariate analyses were used to compare groups and time points.

A total of 38 participants (mean age, 50.8; women, 75%; White, 75%; vestibular migraine diagnosis, 88%; history of migraine headaches, 93%) were included in the modified intention to treat analysis, of whom 21 received placebo and 17 received galcanezumab.

The change in VM-PATHI score from baseline to month 4 was -5.1 points (95% CI, -13.0 to 2.7) in the placebo group and -14.8 points (95% CI, -23.0 to -6.5) in the intervention group. The difference of 9.6 points was found to be statistically significant with a 1-tailed t-test (P =.044), but not with a 2-tailed t-test (P =.087). A medium effect size was observed.

The change in Dizziness Handicap Inventory score from baseline to month 4 was -8.3 points (95% CI, -15.0 to 1.6) in the placebo group and -22.0 points (95% CI, -31.9 to -12.1) in the intervention group.  The difference of 14.4 points was found to be statistically significant with a 2-tailed t-test (P =.018) and a large effect size was observed.

In the placebo and intervention groups, the number of definite dizziness days per month decreased from 18.0 days at baseline to 12.5 days at month 4 and from 17.9 days at baseline to 6.6 days at month 4, respectively (difference, -5.7 days; 95% CI, -10.7 to -0.7; P =.026).

A total of 12 adverse events (AEs) occurred among 11 participants over the course of the study period. Four AEs (injection site reactions, n=2; worsening of vestibular migraine, n=2) were observed among recipients of the intervention and 8 AEs (injection site soreness, n=1; injection site burning, n=1; weight gain, n=1; low blood pressure, n=1; increased headaches, n=1; hair loss, n=1; palpitations, n=1; constipation, n=1) were observed among those who received placebo. No serious AEs were observed.

Study limitations include the small-scale and single-center design, premature study termination, and pharmacist error.

“[T]reatment of VM [vestibular migraine] with galcanezumab improved the

count of DDDs [definite dizzy days], dizziness handicap, and VM disease severity compared to placebo,” the study authors concluded.

Disclosure: This research was supported by Eli Lilly and Company. One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.