Last updated 34 days ago

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

456 patients around the world
Available in United States, Colombia
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 participants; 12-weeks for Group 2 participants) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug). The study intends to enroll 456 participants (376 adolescents and up to 80 children).
Amgen
456Patients around the world
This study is for people with
Migraine
Requirements for the patient
To 17 Years
All Gender
Medical requirements
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