Colorado Springs Neurological Associates | Colorado Springs, CO
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About
This study will 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 study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Full description
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).
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Criteria to be assessed prospectively during the 4-week baseline phase and confirmed before randomizing the participant into the DBTP:
Exclusion Criteria
• History of cluster headache or hemiplegic migraine headache.
No therapeutic response with greater than 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
The following scenarios do not constitute lack of therapeutic response:
Taken the following for any indication in any month during the 2 months before the start of the baseline phase, or during the baseline phase:
Primary purpose
Allocation
Interventional model
Masking
456 participants in 3 patient groups, including a placebo group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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