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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DELTA(9)-TETRAHYDROCANNABINOLIC ACID

  CANNABIDIOL
• Medical condition to be studied:
  Neuralgia
• Additional medical condition(s):
  Chemotherapy-induced neuropathic pain

Population studied

• Short description of the study population:
  ~300 patients with the cannabinoid under evaluation for whom the cost coverage has been accepted by the responsible statutory insurance company; ~ 100 patients for whom cost coverage has been rejected by the responsible statutory insurance company and who received a standard of care treatment. Observation time is 12 weeks from date of the decision regarding cost coverage.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  12-week Efficacy and tolerability of a balanced 10:10 THC:CBD full spectrum extract vs. standard of care.
• Outcomes:
  Primary endpoint of this study is the number of patients who reported either an absolute improvement equal to or greater than the minimal clinical important difference or a relative improvement equal to or greater than 30% vs. baseline for a) average 24-hour pain intensity, pain-related disabilities in daily life, pain-related sleep disturbances, and neuropathic pain phenomenology., Efficacy: absolute/relative treatment-related changes in average 24-hour pain intensity, pain-related disabilities in daily life, pain-related sleep disturbances, and neuropathic pain phenotype at end of week 12 vs. baseline. Safety/tolerability: number and spectrum of reported adverse drug reactions, percentage of patients affected by adverse drug reactions.
• Data analysis plan:
  Descriptive and inferential statistical analyses will be performed. For continuous variables, descriptive statistics will be summarized by the number of patients (n), the mean, standard deviation (SD), 95% confidence intervals (95%-CI) of the mean, median, and range (minimum – maximum) values. For categorical and ordinal variables data will be summarized by frequency number (n), percentage (%) and (where appropriate) adjusted percentage (a%) of participants in each category, incl. 95% confidence intervals. For between groups comparisons of 2x2 contingency tables with a dichotomous/binomial trait McNemar´s test (with the Edwards correction) will be applied, and Pearson's chi-squared tests will be used for categorial variables with multinomial expressions. Between groups comparisons of continuous variables will be applied dependent on the data distribution: for normally distributed data paired samples t-tests and for non-normal distributions Wilcoxon´s signed rank test will be used.