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Table 1 Overview of all clinical studies

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

StudyTrial registrationDesignPopulationTreatment periodRandomization ratiosRandomized patientsPatient completion
CGABaNCT02163993Phase 2b, randomized, DB, placebo-controlled dose-ranging studyPatients with episodic migraine3-month DB treatment phase2:1:1:1:1N = 410Completed DB Treatment Phase: 375
Completed Post-treatment (washout): 361
PBO137
GMB 5 mg68
GMB 50 mg68
GMB 120 mg70
GMB 300 mg67
EVOLVE-1NCT02614183Phase 3, randomized, DB, placebo-controlled, parallel group studyPatients with episodic migraine6-month DB treatment phase2:1:1N = 858Completed DB Treatment Phase: 703
Completed Post-treatment (washout): 704
PBO433
GMB 120 mg213
GMB 240 mg212
EVOLVE-2NCT02614196Phase 3, randomized, DB, placebo-controlled, parallel group studyPatients with episodic migraine6-month DB treatment phase2:1:1N = 915Completed DB Treatment Phase: 785
Completed Post-treatment (washout): 797
PBO461
GMB 120 mg231
GMB 240 mg223
REGAINbNCT02614261Phase 3, randomized, DB, placebo-controlled, parallel group studyPatients with chronic migraine3-month DB treatment phase;
9-month OL treatment phase
2:1:1N = 1113Completed DB Treatment Phase: 1037
Completed OL Treatment: 555
Completed Post-treatment (washout): 218
PBO558
GMB 120 mg278
GMB 240 mg277
CGAJNCT02614287Phase 3, randomized, long-term, OL safety studyPatients with episodic or chronic migraine12-month OL treatment phase1:1N = 270Completed OL Treatment: 210
Completed Post-treatment (washout): 198
GMB 120 mg135
GMB 240 mg135
  1. Abbreviations: DB Double-blind, GMB Galcanezumab, NCTclinicaltrials.gov registration, OL Open-label, PBO Placebo
  2. aOnly the patients in the GMB 120 mg dose-group were included in the analyses
  3. bGiven the flexible dosing of the open-label treatment phase, some patients had a modal treatment that is different from their randomized treatment. A patient who was randomized to GMB 120 mg in the DB treatment phase and then received additional injections of GMB 240 mg in the flexible OL treatment phase could eventually have a modal dose of GMB 240 mg