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. 2020 Apr 27;40(9):978–989. doi: 10.1177/0333102420920642

Table 1.

Study designs for phase 3 galcanezumab studies in patients with episodic and chronic migraine.

Study name Migraine population Active treatment period* Number randomized
Placebo Galcanezumab120 mg+/240 mg
REGAIN Chronic 3-month double-blind, placebo-controlled, followed by optional 9-month open-label period 558 278/277
EVOLVE-1 Episodic 6-month double-blind, placebo-controlled 433 213/212
EVOLVE-2 Episodic 6-month double-blind, placebo-controlled 461 231/223
Study CGAJ Episodic or chronic 12-month open-label 135/135

Notes:

*

The active treatment period of all four studies was followed by a 4-month post-treatment follow-up (washout) period.

+

Patients randomized to the 120 mg arm received an initial loading dose of 240 mg.

The open-label extension and follow-up periods of REGAIN were ongoing at the time of these analyses.