Pregabalin Formulation Effectiveness in Real-World Early Response Extended-release versus immediate-release pregabalin in new patients in routine care for neuropathic pain (PREFER)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001093
• Study ID:
  1000001093
• Official title and acronym:
  Pregabalin Formulation Effectiveness in Real-World Early Response Extended-release versus immediate-release pregabalin in new patients in routine care for neuropathic pain (PREFER)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  PREFER (Pregabalin Effectiveness and Realized Treatment Benefit in Routine Care) is a non-interventional comparative effectiveness study designed as a target trial emulation using prospectively documented routine clinical practice data from the German Pain e-Registry. The study evaluates adult patients with neuropathic or neuropathic-dominated pain initiating treatment with extended-release (ER) or immediate-release (IR) pregabalin. Eligible patients are followed for up to 12 weeks after treatment initiation. To improve comparability between treatment groups and reduce confounding by indication, patients receiving ER and IR pregabalin are balanced using propensity score matching based on predefined baseline characteristics. The study evaluates effectiveness, tolerability, dose development and optimisation, treatment persistence, and patient-reported outcomes covering pain, pain-related functioning, health-related quality of life, psychological burden and neuropathic pain characteristics. In addition to conventional comparative effectiveness analyses, prospectively specified secondary analyses evaluate Realized Treatment Benefit (RTB), a longitudinal approach that relates observed improvement to the benefit individually achievable from baseline and integrates the magnitude, timing and sustainability of treatment benefit over the observation period. PREFER aims to characterize differences between ER and IR pregabalin under routine clinical conditions and to investigate how treatment benefit develops and is realized over time.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned:01/05/2026

Actual:06/05/2026

Study start date

Planned:04/05/2026

Actual:11/05/2026

Data analysis start date

Planned:04/05/2026

Actual:11/05/2026

Date of final study report

Planned:08/06/2026

Actual:12/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Study has been supported through an unrestricted scientific grant of ARISTO Pharma GmbH Germany

Regulatory

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