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Clinical trial to evaluate the efficacy and safety of erenumab in children (aged 6 to < 12 years) and adolescents (aged 12 to < 18 years) with episodic migraine.
THIS STUDY IS BEING CONDUCTED TO LEARN MORE ABOUT ERENUMAB IN CHILDREN (AGED 6 TO <12 YEARS) AND ADOLESCENTS (AGED 12 TO <18 YEARS) WITH EPISODIC MIGRAINE. THIS STUDY WILL DETERMINE WHETHER ERENUMAB IS EFFECTIVE IN PREVENTING MIGRANES, WHETHER IT IS SAFE AND WELL TOLERATED BY CHILDREN AND ADOLESCENTS, AND WHETHER IT CAUSES ANY SIDE EFFECTS. THIS STUDY WILL ALSO EVALUATE WHAT DOSE OF ERENUMAB IS SAFE AND EFFECTIVE IN CHILDREN AND ADOLESCENTS. TO DO THIS, ERENUMAB WILL BE COMPARED WITH PLACEBO DURING THE INITIAL 24 WEEKS OF TREATMENT. THE PLACEBO WILL LOOK THE SAME AS ERENUMAB, BUT WILL NOT CONTAIN ANY ACTIVE INGREDIENTS. RECEIVING PLACEBO IS THE SAME AS RECEIVING AN INJECTION OF SALINE.
Technical Summary
- PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ERENUMAB IN CHILDREN (AGED 6 TO < 12 YEARS) AND ADOLESCENTS (AGED 12 TO < 18 YEARS) WITH EPISODIC MIGRAINE (OASIS PEDIATRIC [ME]). IMMUNOTHERAPY
- Code EudraCT: 2017-002397-39
- Protocol number: 20150125
- Promoter: Amgen, S.A.
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