Effectiveness and tolerability of the THC:CBD oromucosal spray vs. dronabinol as add-on measure in patients with severe neuropathic pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (SATIDRON)

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

  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Sativex, Dronabinol
• Medical condition to be studied:
  Neuropathy peripheral

Population studied

• 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:
  674

Study design details

• Main study objective:
  Main objective of this analysis is to gain further insight into the differential effects and thebenefit-risk profile (BRP) of THC:CBD oromucosal spray vs. dronabinol given add-on to patients with elsewhere refractory severe chronic neuropathic pain under real life conditions.
• Outcomes:
  Primary efficacy endpoint is an aggregated 9-factor symptom relief score (ASR-9) defined as a composite of nine efficacy parameters (at least 50% improvement of pain, pain-related disabilities in daily life, sleep, overall wellbeing, physical and mental quality-of-life,depression, anxiety and stress, each at end of observation vs. baseline). Secondary endpoint is the spectrum of treatment emergent adverse reactions (TEAEs) and the proportion of related treatment discontinuations.
• Data analysis plan:
  Exploratory analysis of anonymized 24-week routine/open-label data of the German Paine-Registry (GPR) on adult SCNP patients, in whom a treatment with THC:CBD oromucosal spray or dronabinol has been initiated in compliance with the current German prescribing regulations between March 10th and December 31st, 2019. No formal sample size analysis will be performed. Data analyses will be performed for all registered patients who took at least one dose of the THC/CBD oromucosal spray and comparable patients treated with dronabinol, who had at least one post-baseline/post-dose measure (modified intent-to-treat approach). Analyses will be performed only for patients with neuropathic pain identified with the modified 7-dimensional patient-reported pain detect questionnaire (PDQ7).