Treatment persistence and effectiveness of CGRP monoclonal antibodies versus high evidence conventional oral preventive treatments in adolescents with high-burden migraine: an exploratory retrospective analysis of depersonalized real-world-data from the German Pain e-Registry (GPeR). (PRIME-Teen)

Study identification

• EU PAS number:
  EUPAS1000000879
• Study ID:
  1000000879
• Official title and acronym:
  Treatment persistence and effectiveness of CGRP monoclonal antibodies versus high evidence conventional oral preventive treatments in adolescents with high-burden migraine: an exploratory retrospective analysis of depersonalized real-world-data from the German Pain e-Registry (GPeR). (PRIME-Teen)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is an observational cohort study taht retrospectively analyzed depersonalized routine care data from adolescents with migraine treated with high evidence conventional oral preventives (HECP) or CGRP-mABs in routine care in the German Pain e-Registry. Patient data sets were included if they provide information on at least one 6-month treatment period, each with baseline (BL) and follow-up documentation, for both treatments to allow intraindividual comparisons. Primary endpoint (PE) was achievement of a composite of treatment persistence and ≥50% reduction in monthly migraine days (MMD). Secondary outcomes included changes in MMD with acute medication, (MMDAM), migraine-related sick leave days (MMSLD), disability (MIDAS), sleep, psychological burden, and quality of life.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Networks

German Pain e-Registry

Study timelines

Date when funding contract was signed

Planned:01/10/2025

Actual:01/10/2025

Study start date

Planned:02/10/2025

Actual:02/10/2025

Data analysis start date

Planned:02/10/2025

Actual:02/10/2025

Date of final study report

Planned:31/10/2025

Actual:31/10/2025

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable