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A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501100-94-00
Acronym
M21-201
Enrollment
163
Registered
2023-07-31
Start date
2023-11-08
Completion date
Unknown
Last updated
2026-01-23

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 mean monthly migraine days across the 12-week treatment period.

Detailed description

Change from baseline in mean monthly headache days across the 12-week treatment period., Change from baseline in mean monthly acute medication use days across the 12-week treatment period., Achievement of at least a 50% reduction in 3-month average of monthly migraine days., Change from baseline in the PedsQL total score at Week 12., Change from baseline in the PedMIDAS total score at Week 12., Change from baseline in mean monthly headache days of at least moderate severity across the 12-week treatment period.

Interventions

DRUGAtogepant
DRUGPlacebo for Atogepant tablets 10mg

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Change from baseline in mean monthly migraine days across the 12-week treatment period.

Secondary

MeasureTime frame
Change from baseline in mean monthly headache days across the 12-week treatment period., Change from baseline in mean monthly acute medication use days across the 12-week treatment period., Achievement of at least a 50% reduction in 3-month average of monthly migraine days., Change from baseline in the PedsQL total score at Week 12., Change from baseline in the PedMIDAS total score at Week 12., Change from baseline in mean monthly headache days of at least moderate severity across the 12-week treatment period.

Countries

Belgium, Denmark, France, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

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