Table 1.
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.