Skip to content

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513836-28-00
Acronym
M23-712
Enrollment
95
Registered
2025-05-22
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-12-22

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 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., Percentage of Participants who Achieve at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days., Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score at Week 12., Change from Baseline on the Pediatric Migraine Disability Assessment (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

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., Percentage of Participants who Achieve at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days., Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score at Week 12., Change from Baseline on the Pediatric Migraine Disability Assessment (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

Denmark, Hungary, Italy, Netherlands, Poland

Outcome results

None listed

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