PHILADELPHIA – Treatment with monthly subcutaneous injections of galcanezumab 300 mg may not reduce weekly chronic cluster headache (CCH) attack frequency, according to study results presented at the 61st Annual Scientific Meeting of the American Headache Society, held July 11 to 14 in Philadelphia, Pennsylvania.
Galcanezumab is a humanized monoclonal antibody specific to calcitonin gene-related peptide.
The study included adults (n=237; ages 18-65)with CCH who met the International Classification of Headache Disorder-3 beta diagnostic criteria and who had ≥1 attack every other day and ≤8 attacks per day during the study’s 2-week baseline period. Participants were randomly assigned to receive galcanezumab 300 mg (n=117) or placebo (n=120). Treatment consisted of monthly subcutaneous injections over a 12-week treatment period followed by an optional 52-week open-label extension. All participants were followed-up for 16 weeks posttreatment.
During the study period, participants were asked to record daily, using an electronic diary, the number of headache attacks, average pain severity, average attack duration, and use of acute medication. The study’s primary end point was overall mean change in weekly attack frequency from baseline to weeks 1 through 12. Secondary end points were mean percentage of participants with ≥50% reduction in weekly attack frequency during the treatment period compared with baseline and the percentage of participants meeting sustained response through week 12.
Galcanezumab was not found to be superior to placebo in reducing the mean number of weekly cluster headache attacks from weeks 1 to 12 (galcanezumab, -5.4; placebo, -4.6; P =.334). Neither of the secondary end points were met.
During the first 2 week of the treatment period, patients treated with galcanezumab reported a greater mean change from baseline in weekly attack frequency compared with placebo (-4.0 and -1.8, respectively; P =.006). This difference was not maintained in subsequent 2-week intervals of the 12-week treatment period. In addition, during the initial 2 weeks of the treatment period, a greater percentage of participants treated with galcanezumab achieved ≥30% response compared with those treated with placebo (35.2% vs 23.0%, respectively; P =.037).
Dodick D, Goadsby P, Lucas C, et al. Phase 3 placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment. Presented at: 61st Annual Scientific Meeting of the American Headache Society; July 11-14, 2019; Philadelphia, PA.