Effectiveness and tolerability of the THC:CBD oromucosal spray vs. typical oral long-term opioid-analgesics in patients with severe neuropathic (low) back pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (NABILA-NBP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38970
• EU PAS number:
  EUPAS38969
• Study ID:
  38970
• Official title and acronym:
  Effectiveness and tolerability of the THC:CBD oromucosal spray vs. typical oral long-term opioid-analgesics in patients with severe neuropathic (low) back pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (NABILA-NBP)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Cross-sectional retrospective analysis of anonymized real-world data provided by the German Pain e-Registry on the effectiveness, safety and tolerability of an oromucosal spray containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) vs. typical oral long-term opioid-analgesics, given as add-on treatment in patients with severe chronic neuropathic (low) back pain (NBP) in routine clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 30/09/2020

Study start date

Planned: 01/10/2020

Data analysis start date

Planned: 15/10/2020

Date of final study report

Planned: 31/12/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Almirall Hermal GmbH Germany, IFNAP - Institute of Neurological Sciences

Regulatory

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