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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])

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504928-26-00
Acronym
20160354
Enrollment
101
Registered
2024-07-17
Start date
2019-07-19
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine

Brief summary

Change from baseline in MMD to week 9 through week 12 (month 3) of the DBTP., The target population, which is the adolescent subjects (12 to < 18 years of age) diagnosed with CM., The primary endpoint, which is the change in MMD from baseline to week 9 through week 12 (month 3) of the DBTP., The summary measure, which is the difference between the mean of the primary endpoint for the combined erenumab dose group and placebo., The intercurrent event is treatment discontinuation. The treatment effect will be estimated for all randomized subjects regardless of adherence to treatment.

Detailed description

Change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP., Achievement of at least 50% reduction in MMD from baseline to week 9 through week 12 (month 3) of the DBTP., Change from baseline in MMD to the average of the first 3 months (week 1 through week 12) of the DBTP., Change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP., Change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to (month 3) of the DBTP

Interventions

DRUGErenumab

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Change from baseline in MMD to week 9 through week 12 (month 3) of the DBTP., The target population, which is the adolescent subjects (12 to < 18 years of age) diagnosed with CM., The primary endpoint, which is the change in MMD from baseline to week 9 through week 12 (month 3) of the DBTP., The summary measure, which is the difference between the mean of the primary endpoint for the combined erenumab dose group and placebo., The intercurrent event is treatment discontinuation. The treatment effect will be estimated for all randomized subjects regardless of adherence to treatment.

Secondary

MeasureTime frame
Change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP., Achievement of at least 50% reduction in MMD from baseline to week 9 through week 12 (month 3) of the DBTP., Change from baseline in MMD to the average of the first 3 months (week 1 through week 12) of the DBTP., Change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP., Change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to (month 3) of the DBTP

Countries

Belgium, Germany, Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026