Investigational Drug Reduces Cluster Headache Attacks in Phase 3 Study

Eli Lilly’s galcanezumab met its primary endpoint in a phase 3 study evaluating its use in the prevention of episodic cluster headaches.

Eli Lilly’s investigational drug for the prevention of episodic cluster headache met its primary endpoint in a phase 3 study, the company announced in a press release.

In a trial of patients with episodic cluster headache, those who were treated with galcanezumab demonstrated a statistically significant difference in the reduction of weekly cluster headache attacks compared with placebo across weeks 1 to 3.

According to the data, a statistically significant greater percentage of patients treated with galcanezumab also achieved at least a 50% reduction in weekly cluster headache attacks compared with placebo at week 3.

The study included a 2-month treatment period comparing galcanezumab (300 mg once-monthly) to placebo in 106 patients with episodic cluster headache. Patients who participated in the trial had an average of 17.5 cluster headache attacks per week at baseline.

Eight percent of patients treated with galcanezumab discontinued treatment compared with 21% of patients treated with placebo. Four percent discontinued treatment due to adverse events compared with 2% of patients treated with placebo. Two percent of patients who took galcanezumab discontinued due to lack of efficacy versus 14% of patients treated with placebo.

“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,” Christi Shaw, president of Lilly Bio-Medicines, said in the press release.

Overall, the safety and tolerability profile were consistent with previous studies that evaluated galcanezumab for the prevention of migraine.

In May 2017, Lily reported positive data from three phase 3 studies evaluating galcanezumab for the treatment of chronic and episodic migraine.

In addition, Lilly conducted a separate phase 3 trial for patients with chronic cluster headache; however, this study did not meet its primary endpoint.

These studies, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache, according to the press release.

Reference

Lilly’s Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache [news release]. Indianapolis. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lillys-galcanezumab-meets-primary-endpoint-phase-3-study. Accessed May 15, 2018.