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Table 1 Clinical trials included in analyses

From: 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

Phase 3 placebo-controlled trials
 EVOLVE-1EVOLVE-2REGAIN
NCT numberNCT02614183NCT02614196NCT02614261
No. of patients randomized and treated (ITT)8589151113
Study centers90 in US and Canada109 in Asia, Europe, North and South America116 in Asia, Europe, North and South America
Headache frequency4-14 migraine headache days/month (episodic migraine)≥15 headache days/montha (chronic migraine)
Double-blind6 months3 months
Open labelNone9 months
Additional migraine preventive medicationsNot permittedStable doses of allowed treatments permittedb
Trial phase3
PBO-controlledYes
Treatment armsGMB 120 mg with 240 mg loading dose
GMB 240 mg
PBO
Treatment regimenSubcutaneous injection every month
Other clinical trials
 ART-01CGABCGAJ
NCT numberNCT01625988NCT02163993NCT02614287
No. of patients randomized and treated (ITT)217410270
Study centers35 in US37 in US28 in North America and Europe
Headache frequency4 – 14 migraine headache days/28 days4 – 14 migraine headache days/28 days≥4 migraine headache days/month
Double-blind12 weeks12 weeksnone
Open labelNoneNone12 months
Additional migraine preventive medicationsNot permittedNot permittedNot permitted
Trial phase22b3
PBO-controlledYesYesNo
Treatment armsGMB 150 mg
PBO
GMB 300 mg
GMB 120 mg
GMB 50 mg
GMB 5 mg
PBO
GMB 120 mg
GMB 240 mg
Treatment regimenSubcutaneous injection every 2 weeksSubcutaneous injection every 28 daysSubcutaneous injection every month
  1. Abbreviations: GMB galcanezumab, ITT intent-to-treat, NCT national clinical trial, PBO placebo
  2. aAt least eight of the monthly headache days were migraine headache days
  3. bPermitted migraine preventive medications included topiramate and propranolol
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