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. 2020 Nov 29;60(10):2304–2319. doi: 10.1111/head.14013

Table 1.

Clinical Trials Included in Analyses

EVOLVE‐1 EVOLVE‐2 REGAIN
NCT number NCT02614183 NCT02614196 NCT02614261
Number of patients randomized and treated (ITT) 858 915 1113
Study centers 90 in United States and Canada 109 in Asia, Europe, North, and South America 116 in Asia, Europe, North, and South America
Headache frequency 4‐14 migraine headache days/month (episodic migraine) 4‐14 migraine headache days/month (episodic migraine) ≥15 headache days/month (chronic migraine)
Baseline period 30‐40 days 30‐40 days 30‐40 days
Double‐blind period 6 months 6 months 3 months
Follow‐up period 4 months 4 months 4 months
Additional migraine preventive medications Not permitted Not permitted Stable doses of allowed treatments permitted
Trial phase 3 3 3
PBO‐controlled Yes Yes Yes
Treatment groups GMB 120 mg with 240 mg loading dose GMB 120 mg with 240 mg loading dose GMB 120 mg with 240 mg loading dose
GMB 240 mg GMB 240 mg GMB 240 mg
PBO PBO PBO
Treatment regimen Monthly subcutaneous injection Monthly subcutaneous injection Monthly subcutaneous injection

At least 8 of the monthly headache days were migraine headache days.

Permitted migraine preventive medications included topiramate and propranolol.

GMB = galcanezumab; ITT = intent‐to‐treat population; NCT = national clinical trial; PBO = placebo.