Study identification

EU PAS number

EUPAS1000000490

Study ID

1000000490

Official title and acronym

A retrospective parallel group dual-cohort study of the German Pain e-Registry on the efficacy and safety of CBD-rich oral cannabis extract vs. THC/dronabinol in older patients with therapy-resistant or chronic pain "CARE"

DARWIN EU® study

No

Study countries

Germany

Study description

CARE is a non-interventional, retrospective analysis of depersonalized data from the German Pain e-Registry, in which routine data from everyday care are used to evaluate the efficacy and tolerability of cannabis-based medications in older adults with intractable pain.
The primary characteristic of the treatment documentation is the prescription of CBD-rich (i.e. CBD content > THC content) oral extracts or dronabinol/THC for the treatment of therapy-resistant ± chronic pain within the scope of the Glaw to amend narcotics and other regulations (§ 31 (6) SGB V) and the use of the online documentation software iDocLive® for standardized observation of the course of treatment in accordance with usual care standards.
As the treatment-justifying indication for the present evaluation, both parties agree on the presence of pain that is difficult to treat by other means (in accordance with the legal requirements for the use of cannabis-based drugs).
To ensure comparable baseline findings, a so-called propensity score matching (PSM) is carried out, in which each patient treated with dronabinol/THC is matched with a patient treated with a CBD-rich oral extract [with regard to age, sex, pain phenotype, duration of illness, severity of impairment, chronicity stage and analgesic co-medication (ATC group)] comparable patient is assigned to each patient treated with dronabinol/THC in a so-called “1:1 matching” (caliper 0.15, “without replacement”).
All analyses are exploratory. The primary endpoint is the absence of treatment discontinuation due to an ADR in conjunction with clinically relevant relief of pain and pain-related impairments in daily life (each with an improvement of at least 20 mm VAS and/or 30% vs. BL).

Study status

Finalised
Research institutions and networks

Institutions

O.Meany-MDPM
First published:
01/02/2024
Institution

Contact details

Michael Ueberall

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

IFNAP
private Institute of Neurological Sciences
Nordostpark 51
90411 Nürnberg

STADAPHARM GmbH
Stadastraße 2-18
61118 Bad Vilbel
Deutschland
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable