A Randomized, Placebo-Controlled Study of Galcanezumab in Patients with Treatment-Resistant Migraine: Double-Blind Results from the CONQUER Study (162)

Objective: CONQUER assessed galcanezumab efficacy and safety in patients with migraine who had not benefited from multiple previous migraine preventive treatments. Background: The efficacy and safety of galcanezumab have been previously established in three Phase-3 clinical trials – EVOLVE-1, EVOLVE-2, and REGAIN. Design/Methods: In this phase 3, double-blind study, patients were aged 18–75 years, met criteria for episodic or chronic migraine, had 4–29 migraine headache days per month, and had 2–4 migraine preventive medication category failures in the past 10 years. Eligible patients were randomized 1:1 to receive galcanezumab 120 mg/month (with 240-mg loading dose; N=232) or placebo (N=230). Headache information was captured in a daily electronic diary device. Primary endpoint was overall mean change from baseline in number of monthly migraine headache days across Months 1–3. Key secondary endpoints included ≥50%, ≥75%, or 100% reduction in monthly migraine headache days across Months 1–3 and change from baseline on the Migraine-Specific Quality of Life-Role Function Restrictive domain at Month 3. Efficacy measures were evaluated for both intent-to-treat total population and episodic migraine (EM) subpopulation. Results: Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo. The galcanezumab group averaged 4.1 fewer monthly migraine headache days from a baseline of 13.4, and the placebo group averaged 1.0 fewer from a baseline of 13.0 (between-group difference –3.1; p Conclusions: Galcanezumab was superior to placebo in preventive treatment of migraine and was safe and well tolerated in patients who had previous failures to standard-of-care preventive treatments. Disclosure: Dr. Mulleners has received research support from Eli Lilly and Company. Dr. Kim has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli-Lilly, Teva, Novartis, Allergan and SK chemical. Dr. Kim has received personal compensation in an editorial capacity for Journal of Clinical Neurology. Dr. Lainez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Autonomic Technologies, ,Bial, Chiesi, Eli Lily, Medtronic, Novartis, Teva and UCB. Dr. Lainez has received research support from Amgen, Boehringher, Eissai, ElectroCore, Eli Lily, Novartis, Otsuka, Roche and Teva. Dr. Lanteri-Minet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Grunenthal, Eli Lilly and Company, Medtronic, Novartis, ReckittBenckiser, Sanofi-Aventis, Teva. Dr. Lanteri-Minet has received research support from Medtronic, Teva. Dr. Aurora has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company and Impel NeuroPharma Dr. Aurora has received compensation for serving on the Board of Directors of Eli Lilly and Company. Dr. Aurora holds stock and/or stock options in Eli Lilly and Company. Dr. Aurora has received research support from Eli Lilly and Company.Dr. Nichols has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eli Lilly and Company. Dr. Nichols holds stock and/or stock options in Eli Lilly and Company. Dr. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Tockhorn-Heidenreich has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Tockhorn-Heidenreich holds stock and/or stock options in Eli Lilly and Company which sponsored research in which Dr. Tockhorn-Heidenreich was involved as an investigator. Dr. Tockhorn-Heidenreich holds stock and/or stock options in Eli Lilly and Company.Dr. Detke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company.