Capsaicin 179 mg cutaneous patch treatment in adult patients with peripheral localized neuropathic pain – A retrospective study to document initial/progressive response and develop a responder profiling algorithm based on the number of treatments in a longitudinal analysis of depersonalized bio-psycho-social real-world data of a subset of the German Pain e-Registry (CASPAR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000106
• EU PAS number:
  EUPAS1000000106
• Study ID:
  1000000106
• Official title and acronym:
  Capsaicin 179 mg cutaneous patch treatment in adult patients with peripheral localized neuropathic pain – A retrospective study to document initial/progressive response and develop a responder profiling algorithm based on the number of treatments in a longitudinal analysis of depersonalized bio-psycho-social real-world data of a subset of the German Pain e-Registry (CASPAR)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  CASPAR is an exploratory, non-interventional, post-marketing, open-label, retrospective, flexible-dose, longitudinal (at least 1-year) single-cohort-study using depersonalized data of a subset of the German Pain e-Registry (GPeR; until December 31st, 2022) on patients who were treated as part of a special/integrated care contract of the Integrative Managed Care (IMC) Corporation - so-called IV Pain concept - for at least 12 months to assess the effectiveness and global response of capsaicin 179 mg patches in adult patients who are deemed to be in need of such a treatment according to the mutual / shared decision of the responsible physicians and affected patients. Based on the evaluated early (to 1st) and delayed (to 3rd patch) response to treatment, demographic and bio-psycho-social data are planned to be traced backward to baseline to identify critical parameters and their predictive value for a beneficial response to a treatment with capsaicin 179 mg to identify clinically useful predictors for response.; This study exclusively evaluates the effectiveness of the topical application of capsaicin 179 mg cutaneous patches in patients with locally circumscribed peripheral neuropathic pain. Analyses base on anonymized real-world data of a subset of the GPeR – a national web-based pain treatment registry developed by the Institute of Neurological Sciences and hosted by the O.Meany-MDPM corporaration – that have originally been prospectively sampled for routine care purposes as part of a special/integrated care contract termed IV-Pain developed by the Integrative Managed Care (IMC) corporation. Data are entered by using electronic case report forms as provided by the GPeR and the related online documentation service iDocLive®.; Analyses are planned for definite patient cohorts characterized by identical/comparable pain mechanisms/causes - such as pstherpetic neuralgia (PHN), peripheral nerve injury (PNI), peripheral diabetic polyneuropathy (PDPN), and others (OTH).
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 04/09/2023

Actual: 04/09/2023

Study start date

Planned: 01/10/2023

Actual: 01/10/2023

Data analysis start date

Planned: 15/10/2023

Actual: 15/10/2023

Date of final study report

Planned: 01/05/2024

Actual: 01/04/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The retrospective GPeR (IV-S) study CASPAR is sponsored in part by Grünenthal (80%) and IFNAP (20%).

Regulatory

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