Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

Table 1 Overview of all clinical studies

Study	Trial registration	Design	Population	Treatment period	Randomization ratios	Randomized patients		Patient completion
CGAB^a	NCT02163993	Phase 2b, randomized, DB, placebo-controlled dose-ranging study	Patients with episodic migraine	3-month DB treatment phase	2:1:1:1:1	N = 410		Completed DB Treatment Phase: 375 Completed Post-treatment (washout): 361
						PBO	137
						GMB 5 mg	68
						GMB 50 mg	68
						GMB 120 mg	70
						GMB 300 mg	67
EVOLVE-1	NCT02614183	Phase 3, randomized, DB, placebo-controlled, parallel group study	Patients with episodic migraine	6-month DB treatment phase	2:1:1	N = 858		Completed DB Treatment Phase: 703 Completed Post-treatment (washout): 704
						PBO	433
						GMB 120 mg	213
						GMB 240 mg	212
EVOLVE-2	NCT02614196	Phase 3, randomized, DB, placebo-controlled, parallel group study	Patients with episodic migraine	6-month DB treatment phase	2:1:1	N = 915		Completed DB Treatment Phase: 785 Completed Post-treatment (washout): 797
						PBO	461
						GMB 120 mg	231
						GMB 240 mg	223
REGAIN^b	NCT02614261	Phase 3, randomized, DB, placebo-controlled, parallel group study	Patients with chronic migraine	3-month DB treatment phase; 9-month OL treatment phase	2:1:1	N = 1113		Completed DB Treatment Phase: 1037 Completed OL Treatment: 555 Completed Post-treatment (washout): 218
						PBO	558
						GMB 120 mg	278
						GMB 240 mg	277
CGAJ	NCT02614287	Phase 3, randomized, long-term, OL safety study	Patients with episodic or chronic migraine	12-month OL treatment phase	1:1	N = 270		Completed OL Treatment: 210 Completed Post-treatment (washout): 198
						GMB 120 mg	135
						GMB 240 mg	135

Abbreviations: DB Double-blind, GMB Galcanezumab, NCTclinicaltrials.gov registration, OL Open-label, PBO Placebo
^aOnly the patients in the GMB 120 mg dose-group were included in the analyses
^bGiven the flexible dosing of the open-label treatment phase, some patients had a modal treatment that is different from their randomized treatment. A patient who was randomized to GMB 120 mg in the DB treatment phase and then received additional injections of GMB 240 mg in the flexible OL treatment phase could eventually have a modal dose of GMB 240 mg

ISSN: 1471-2377