Eli Lilly chronic cluster headache Phase 3 study did not meet primary endpoint
Eli Lilly also conducted a separate Phase 3 study for patients with chronic cluster headache, which represents 10 to 15 percent of cluster headache cases.1 This study did not meet its primary endpoint. Based on results from the episodic cluster headache trial, Lilly is working with regulatory agencies around the world to determine the best path forward. Episodic cluster headache represents 85 to 90 percent of cluster headache cases. These studies, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache to date. "It is hard to articulate the devastating impact that cluster headache can have on those of us living with the disease. 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. "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." The episodic cluster headache study included a two-month treatment period comparing galcanezumab to placebo. Patients with episodic cluster headache treated with galcanezumab 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, the primary endpoint of the study. In May 2017, Lilly announced positive data from three Phase 3 studies evaluating galcanezumab for the treatment of chronic and episodic migraine. In these studies, galcanezumab demonstrated statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses. The FDA is currently reviewing galcanezumab for the prevention of migraine in adults. A decision is expected in the third quarter of 2018.