Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (OASIS(CM))
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (OASIS(CM))
Brief Summary:
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 chronic migraine. The study hypothesis is that in pediatric subjects with chronic 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).
Detailed 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 chronic migraine.
The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the double-blind treatment phase (24 weeks) 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 286 participants (256 adolescents and 30 children).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])
Actual Study Start Date: September 5, 2019
Estimated Primary Completion Date: April 5, 2026
Estimated Study Completion Date: April 4, 2027
Arms:
- Experimental: Dose Level 1
- Experimental: Dose Level 2
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 286 |
| Actual Study start date | 05 September 2019 |
| Estimated study completion date | 04 April 2027 |