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

• PURI:
  https://redirect.ema.europa.eu/resource/106293
• EU PAS number:
  EUPAS106292
• Study ID:
  106293
• 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:
  Open 12-week parallel two-cohort non-interventional evaluation of the efficacy and tolerability of a balanced 10:10 THC:CBD full spectrum cannabinoid extract as add-on treatment to standard of care in adult patients with elsewhere refractory chemotherapy-induced neuropathic pain, based on real-world data provided by the German Pain e-Registry.
• 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