Exploratory non-interventional, open-label, prospective, longitudinal 12-week parallel group study to assess the efficacy and safety of a balanced (10mg:10mg) THC/CBD cannabinoid extract in adult patients* suffering from otherwise refractory chemotherapy-induced neuropathic pain (CINP). (OCEAN)

Study identification

• EU PAS number:
  EUPAS106298
• Study ID:
  106299
• Official title and acronym:
  Exploratory non-interventional, open-label, prospective, longitudinal 12-week parallel group study to assess the efficacy and safety of a balanced (10mg:10mg) THC/CBD cannabinoid extract in adult patients* suffering from otherwise refractory chemotherapy-induced neuropathic pain (CINP). (OCEAN)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Non-interventional 12-week observational two-cohort study to evaluate the efficacy and tolerability of an add-on tretament with a balanced 10:10 THC:CBD cannabinoid in patients with chemotherapy-induced neuropathic pain (CINP) refractory to guideline recommended treatments. Patients will receive treatment with the cannabinoid under evaluation according to national German practice guidelines and dependent of cost coverage by stautory health insurance companies: data of patients who fulfilled the in- and exclusion criteria and for whom their insurances agree to cover the costs of the cannabinoid treatment will be aggregated in cohort A and patients for whom the cost coverage will be declined will be aggregated in cohort B.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 31/03/2023

Actual: 17/05/2023

Study start date

Planned: 09/08/2023

Actual: 09/08/2023

Data analysis start date

Planned: 09/08/2023

Actual: 09/08/2023

Date of final study report

Planned: 09/08/2023

Actual: 09/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Avextra Pharma GmbH

Regulatory

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