Efficacy of Two Dose Regimens of Subcutaneous Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine (S32.005)

Objective: To evaluate two subcutaneous dose regimens of fremanezumab for the preventive treatment of chronic migraine (CM). Background: Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa), selectively targets calcitonin gene-related peptide ligand. Design/Methods: 16-week, multicenter, randomized double-blind, placebo-controlled, parallel-group adult CM study. Patients assigned to 1 of 3 treatment groups: (1) monthly dosing: 675 mg fremanuzemab followed by 225 mg of fremanezumab at months 2 and 3; quarterly dosing: fremanezumab 675 mg at month 1, followed by placebo injections at months 2 and 3; and monthly administration of matching placebo. The primary efficacy endpoint, mean change from baseline (28-day pre-treatment period) to 12-week double-blind treatment period in monthly average number of headache days of at least moderate severity, was analyzed using an analysis of covariance method or the Wilcoxon rank sum test. Results: The mean number of headache days of at least moderate severity was 13.1 days during the 28-day baseline period. Fremanezumab-treated patients had significant reductions in the number of monthly headache days of at least moderate severity vs. placebo (−2.5 days) during the 12-week period after 1st dose, for both dosing regimens [monthly (−4.6 days; p Conclusions: The results confirm the efficacy, safety, tolerability and flexible dosing profile of fremanezumab for the preventive treatment of chronic migraine. Disclosure: Dr. Silberstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Receives honoraria from Alder Biopharmaceuticals; Allergan, Inc.; Amgen; Avanir Pharmaceuticals, Inc.; eNeura; ElectroCore Medical, LLC; Labrys Biologics; Medscape, LLC; Medtronic, Inc.; Neuralieve; NINDS; Pfizer, Inc.; and Teva Pharmaceuticals. Dr. Silberstein has received research support from His employer receives research support from Allergan, Inc.; Amgen; Cumberland Pharmaceuticals, Inc.; ElectroCore Medical, Inc.; Labrys Biologics; Eli Lilly and Company; Merz Pharmaceuticals; and Troy Healthcare. Dr. Aycardi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Bigal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Blankenbiller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Grozinski-Wolff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Ma, MS has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva for employment. Dr. Dodick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Allergan, Amgen, Alder, Dr Reddy’s, Merck, Dr Reddy’s, Promius, eNeura, Eli Lilly & Company, Insys therapeutics, Autonomic Technologies, Teva, Xenon, Tonix, Trigemina, Boston Scientific, GBS, Colucid, Zosano, Laydenburg Thalmann, Biocentric, Biohaven, Magellan, Pfizer (Japan), Charleston Laboratories. Royalties: Oxford University Press and Cambridge University Press (Book Royalty). Uptodate — editorial/honoraria. CME companies honoraria/publishing honoraria/royalites: Chameleon Communications, Medscape, WebMD, Academy for Continued Healthcare Learning, Haymarket Medical Education, Miller Medical Communications, Global Scientific Communications, HealthLogix, Academy for Continued Healthcare Learning, Meeting LogiX, Health LogiX, . Dr. Goadsby has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals, Allergan, Amgen, Electrocore, Eli-Lilly, eNeura, Novartis, Teva.