![]() The primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency during the three-month, double-blind treatment phase with galcanezumab compared with placebo. ![]() Patients who participated in this trial had an average of 18.8 cluster headache attacks per week at baseline. The chronic cluster headache study was a three-month Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of galcanezumab (300 mg once-monthly) administered subcutaneously compared with placebo in 237 patients with chronic cluster headache. The primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency across weeks one to three with galcanezumab compared with placebo. Patients who participated in this trial had an average of 17.5 cluster headache attacks per week at baseline. The episodic cluster headache study was a two-month Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of galcanezumab (300 mg once-monthly) administered subcutaneously compared with placebo in 106 patients with episodic cluster headache. A decision is expected in the third quarter of 2018. The FDA is currently reviewing galcanezumab for the prevention of migraine in adults. In these studies, galcanezumab demonstrated statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses (120 mg and 240 mg once-monthly). In May 2017, Lilly announced positive data from three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab for the treatment of chronic and episodic migraine. Patients with episodic cluster headache treated with galcanezumab (300 mg once-monthly) experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across weeks one to three of the two-month, double-blind treatment period (-8.7 for galcanezumab compared to -5.2 for placebo, p=0.036), the primary endpoint of the study. The episodic cluster headache study included a two-month treatment period comparing galcanezumab to placebo. "We are very excited by these results and galcanezumab's potential as a new treatment option for people living with cluster headache, many of whom have spent years feeling ignored and alone in their struggle." Many people living with cluster headache spend years searching for effective treatment options to help ease an excruciating level of pain," said Bob Wold, a patient living with cluster headache and founder of Clusterbusters, Inc. "It is hard to articulate the devastating impact that cluster headache can have on those of us living with the disease. These studies, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache to date. Episodic cluster headache represents 85 to 90 percent of cluster headache cases. 1 This study did not meet its primary endpoint.īased on results from the episodic cluster headache trial, Lilly is working with regulatory agencies around the world to determine the best path forward. Lilly also conducted a separate Phase 3 study for patients with chronic cluster headache, which represents 10 to 15 percent of cluster headache cases. ![]() "The positive results in episodic cluster headache are truly a landmark moment-both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache." "Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience," said Christi Shaw, president of Lilly Bio-Medicines. Discontinuations due to lack of efficacy occurred in 2 percent of patients treated with galcanezumab, compared to 14 percent of patients treated with placebo. Four percent of patients treated with galcanezumab discontinued treatment during the study due to adverse events compared to 2 percent of patients treated with placebo. ![]() In this study, 8 percent of patients treated with galcanezumab discontinued treatment during the study compared to 21 percent of patients treated with placebo. The observed safety and tolerability profile was consistent with previous studies that evaluated galcanezumab for the prevention of migraine. ![]()
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