xRead - Episodic Vertigo (January 2026)

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HEADACHE

RESULTS

4, found that galcanezumab outperformed placebo at each criterion, but the results were not statistically significant. This included the percentage of participants with 100% reduction for galcanezumab versus placebo (18% vs. 10%, p = 0.475), 75% reduction (53% vs. 38%, p = 0.374), 50% reduction (77% vs. 48%, p = 0.074), and 25% reduction (82% vs. 57%, p = 0.102). Those in the galcanezumab arm experienced greater reductions in both mental and physical subscales of the PROMIS Global Health v1.2, although differences were not statistically significant. For the physical subscale, those in the galcanezumab arm increased their t -­ score by 5.3 points (95% CI 1.7 to 8.9), whereas those in the placebo arm increased their t -score by 1.9 points (95% CI −0.97 to 4.8), two tailed t -test p = 0.129. For the mental subscale, those in the galca nezumab arm increased their t -score by 4.8 points (95% CI 2.1 to 7.5), whereas those in the placebo arm increased their t -score by 3.2 points (95% CI −0.58 to 7.0), two tailed t -test, p = 0.494. At the final study visit, participants were asked to rate how ef fective the medication they received was. The options were “not at all” (0), “helped a little” (1), “it helped a moderate amount” (2), “helped quite a lot” (3), and “I felt cured” (4). Of the 17 participants in the galcanezumab arm, 1 chose “I feel cured,” 6 chose “It helped quite a lot,” 5 chose “It helped a moderate amount,” 4 chose “It helped a little,” and 1 chose “not at all.” Of the 21 participants in the placebo arm, 5 chose “it helped quite a lot,” 7 chose “it helped a little,” and 9 chose “not at all.” Therefore, the mean score in the galcanezumab arm was 2.1 (SD 1.1), and the mean score in the placebo arm was 1.0 (SD 1.2), two tailed t -test with p = 0.0067. The effect size, as measured by Cohen's d , is 0.89, which is considered a large treat ment effect. Dividing treatment into two groups, of little to no help (“helped a little” and “not at all”), and moderate or greater treatment effect (“helped quite a lot,” “I felt cured,” and “it helped a moder ate amount”), 71% of participants in the galcanezumab arm had a moderate or greater treatment effect, compared to 24% of those in the placebo arm (chi-squared test, p = 0.004). Participants were also asked to guess whether they received study drug or placebo, and 71% of participants guessed correctly (chi-squared test, p = 0.008). There were 12 adverse events during the study in 11 partici pants, and no serious adverse events. Four adverse events occurred in the galcanezumab arm, including two participants with injection site reactions of erythema and swelling and two participants with worsening of their VM. The adverse events in the placebo arm in cluded injection site soreness, injection site bruising, participant weight gain (no weight change documented), low blood pressure, increased headaches, hair loss, palpitations, and constipation.

Six hundred eighty participants underwent screening, 53 signed consent, and 40 of those met all inclusion/exclusion criteria and were randomized to either galcanezumab or placebo. This is sum marized in a Consolidated Standards of Reporting Trials (CONSORT) diagram (Figure 1 ). The intent to treat baseline analysis included 40 participants. Of those, two were randomized to placebo and acci dentally given galcanezumab for the third and fourth months (error by the research pharmacy). One other voluntarily left the study for unrelated medical problems (nephrolithiasis). In addition, the study sponsor unexpectedly stopped supplying galcanezumab and pla cebo in March 2023, leading to premature study termination. At that time, two participants were in the baseline month, and another had been treated with placebo. So, of the 40 participants who were randomized and treated, data beyond SV2 were available for 38, and these participants were included in the mITT analysis of results (placebo N = 21, galcanezumab N = 17). The per protocol analysis in cluded 36 participants who were randomized, treated with placebo or galcanezumab, and completed the final study visit. Demographics and disease characteristics were similar between arms (Table 1 ). Most participants were female (75%), with a diagno sis of VM per Barany Society criteria (88%), and White (75%), with a history of migraine headaches (93%). Rates of daily dizziness text completion were the same between arms: galcanezumab 114.6 en tries (standard deviation [SD] 6.8) versus placebo 113.3 entries (SD 8.0), two tailed t -test p = 0.598. There were no other missing data. Study results are summarized in Table 2 . Change in VM-PATHI score from the baseline month to month 4 was the primary outcome measure. Those in the placebo arm dropped 5.1 points (95% confi dence interval [CI] −13.0 to 2.7), while those in the galcanezumab arm dropped 14.8 points (95% CI −23.0 to −6.5). This difference of 9.6 points was statistically significant with a one tailed t -test ( p = 0.044), but not with a two tailed t -test ( p = 0.087). The effect size for the change in VM-PATHI score, calculated with Cohen's d , is 0.56, which is considered a medium effect size. Change in DHI score, from the baseline month to month 4, was a secondary endpoint. Those in the placebo arm dropped 8.3 points (95% CI −15.0 to 1.6), while those in the galcanezumab arm dropped 22.0 points (95% CI −31.9 to −12.1). This difference of 14.4 points was statistically significant with a two tailed t -test ( p = 0.018). The effect size for the change in DHI, calcu lated with Cohen's d , is 0.98, which is considered a large effect size. The count of DDDs per month dropped from 18.0days (SD 7.6) in the baseline month to 12.5days (SD 11.2) in month 4 for those in the placebo arm and from 17.9days (SD 7.9) in the baseline month to 6.6days (SD 7.3) in month 4 for those in the galcanezumab arm, a significant difference ( t -test p = 0.026; Figure 2 ). In addition, the drop in DDDs from baseline to month 3 was 4.7days (SD 7.9) for those in the placebo arm, compared to 10.6days (SD 7.6) for those receiving galcanezumab, a significant difference (two tailed t -test p = 0.025). The effect size for the decrease in DDDs, calculated with Cohen's d , is 1.02, which is considered a large effect size. A responder anal ysis, looking at percent reduction in DDDs from baseline to month

DISCUSSION

To our knowledge, this is the first randomized, controlled trial of a CGRP-blocking medication for VM. In this study, we found that galcanezumab outperformed placebo in the treatment of VM across multiple outcomes. We found that galcanezumab re duced DDDs by 11.3 days, comparing month 4 to baseline. In other