Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials

Table 1 Clinical trials included in analyses

Phase 3 placebo-controlled trials
	EVOLVE-1	EVOLVE-2	REGAIN
NCT number	NCT02614183	NCT02614196	NCT02614261
No. of patients randomized and treated (ITT)	858	915	1113
Study centers	90 in US 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)		≥15 headache days/month^a (chronic migraine)
Double-blind	6 months		3 months
Open label	None		9 months
Additional migraine preventive medications	Not permitted		Stable doses of allowed treatments permitted^b
Trial phase	3
PBO-controlled	Yes
Treatment arms	GMB 120 mg with 240 mg loading dose GMB 240 mg PBO
Treatment regimen	Subcutaneous injection every month
Other clinical trials
	ART-01	CGAB	CGAJ
NCT number	NCT01625988	NCT02163993	NCT02614287
No. of patients randomized and treated (ITT)	217	410	270
Study centers	35 in US	37 in US	28 in North America and Europe
Headache frequency	4 – 14 migraine headache days/28 days	4 – 14 migraine headache days/28 days	≥4 migraine headache days/month
Double-blind	12 weeks	12 weeks	none
Open label	None	None	12 months
Additional migraine preventive medications	Not permitted	Not permitted	Not permitted
Trial phase	2	2b	3
PBO-controlled	Yes	Yes	No
Treatment arms	GMB 150 mg PBO	GMB 300 mg GMB 120 mg GMB 50 mg GMB 5 mg PBO	GMB 120 mg GMB 240 mg
Treatment regimen	Subcutaneous injection every 2 weeks	Subcutaneous injection every 28 days	Subcutaneous injection every month

Abbreviations: GMB galcanezumab, ITT intent-to-treat, NCT national clinical trial, PBO placebo
^aAt least eight of the monthly headache days were migraine headache days
^bPermitted migraine preventive medications included topiramate and propranolol

ISSN: 1129-2377