Longterm, openlabel (doseblinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502917-27-00

Acronym

19379A

Enrollment

285

Registered

2024-04-05

Start date

2023-03-07

Completion date

Unknown

Last updated

2025-09-12

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

Conditions

Migraine

Brief summary

Number of Participants With Treatment Emergent Adverse Events

Detailed description

Free Eptinezumab Plasma Concentration, Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]), Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb), Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36

Interventions

DRUGVYEPTI 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Number of Participants With Treatment Emergent Adverse Events	—

Secondary

Measure	Time frame
Free Eptinezumab Plasma Concentration, Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]), Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb), Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36	—

Countries

Italy, Poland, Portugal, Spain

Outcome results

None listed

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