A propensity score-matched analysis of depersonalized 4-week data from the German Pain e-Registry on the efficacy and tolerability of quinine sulphate vs. pridinol mesylate in the prevention and treatment of painful nocturnal leg cramps (PRISCILA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000105
• EU PAS number:
  EUPAS1000000105
• Study ID:
  1000000105
• Official title and acronym:
  A propensity score-matched analysis of depersonalized 4-week data from the German Pain e-Registry on the efficacy and tolerability of quinine sulphate vs. pridinol mesylate in the prevention and treatment of painful nocturnal leg cramps (PRISCILA)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  PRISCILA is an exploratory, non-interventional, post-marketing, open-label, retrospective parallel-group, comparative 4-week two-cohort-study using depersonalized data of the German Pain e-Registry (until September 30, 2023) to assess the effectiveness of the nonbenzodiazepine antispasmodic pridinol (PRI) compared to quinine sulphate (QUI) in adult patients with advanced nocturnal leg cramps (NLC) who are deemed to be in need of prescription drugs according to the mutual / shared decision of the responsible physicians and affected patients.; ; The primary objective of this study was the evaluation of the 4-week responder rate in comparable patient populations of the German Pain e-Registry (GPeR) with insufficient symptom relief in response to self-medication and/or non-pharmacological countermeasures for NLC who either received a prescription for QUI or alternatively with PRI.; ; Secondary objectives of this study focused on the overall prevalence and severity of adverse drug reactions (ADRs), ADR- and inefficiency-related treatment discontinuations in both study cohorts.; This study used depersonalized data from the German Pain e-Registry (GPeR) which is a nation-wide, web-based pain registry developed by the Institute of Neurological Sciences (IFNAP; Nuernberg) on behalf of the German Pain League (Deutsche Schmerzliga, DSL eV) to support the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin, DGS eV) and its individual members to comply with the legal requirements regarding standardized documentation in pain medicine, as well as to facilitate better pain management care for people in need of it. The GPeR provides patients and physicians with standardized, fully electronic documentation aids that can be adapted to the specifics of each individual case and that collect patient reported information on demography, history, previous and current treatment, pain characteristics and treatment response, within a daily practice setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 18/12/2023

Actual: 18/12/2023

Study start date

Planned: 02/01/2024

Actual: 02/01/2024

Data analysis start date

Planned: 14/01/2024

Actual: 14/01/2024

Date of final study report

Planned: 09/02/2024

Actual: 09/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Study is sponsored by Strathmann GmbH & Co. KG (70%) and by O.Meany-MDPM GmbH (30%).

Regulatory

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