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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 Episodic Migraine (OASIS PEDIATRIC [EM])

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504930-23-00
Acronym
20150125
Enrollment
233
Registered
2024-07-11
Start date
2019-07-19
Completion date
Unknown
Last updated
2025-10-16

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

Conditions

Episodic Migraine

Brief summary

Change from baseline in MMD to week 9 through week 12 (month 3) of the DBTP.

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 week 9 through week 12 (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.

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 week 9 through week 12 (month 3) of the DBTP.

Countries

Belgium, Germany, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

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