Cannabis based medication for the treatment of pain generated in the nervous system.

Phase 1

• Conditions: Peripheral neuropathic pain due to polyneuropathy, postherpetic neuralgia, or peripheral nerve injury (surgical or traumatic).; MedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-005198-38-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-04
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- age = 18 years
- definite or probable peripheral neuropathic pain (IASP criteria) due to polyneuropathy, postherpetic neuralgia or nerve injury
- Diabetic polyneuropathy: definite or probable (criteria: Tesfaye et al. 2010)
- Non-diabetic polyneuropathy: abnormal sensibility and abnormal nerve conduction, intra-epidermal nerve fiber density, or quantitative sensory examination
- duration of pain more than 6 months
- mean of average daily pain (0-10 numeric rating scale) during 1 week more than or equal to 4 and less than 10 and pain present every day

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

- known allergy or important side effects to study drugs
- pregnancy or breast feeding
- severe heart, kidney or liver disease
- schizophrenia, current depression, previous severe depression, previous suicidal behavior, or other important psychiatric diseases
- first degree relatives with schizophrenia
- treatment with strong opioids or tramadol that cannot be stopped
- heavy use of sedatives/hypnotics
- current or previous drug abuse
- current or recent alcohol abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to test if the primary active components of cannabis (tetra-hydro-cannabinol and cannabidiol) provide a clinically relevant pain relief in peripheral neuropathic pain.;Secondary Objective: The secondary objective of the trial is to determine if the primary active component of cannabis in terapeutic doses will cause clinically important deterioration in mental function.;Primary end point(s): The primary end point will be the weekly mean of average daily pain as measured with a 0-10 point numeric rating scale;Timepoint(s) of evaluation of this end point: This end point will be used throughout baseline and the 8 week treatment period and all values will go into the statistical analysis (1 baseline and 8 treatment values)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary pain end points will be different pain dimensions measured with neuropathic pain symptom inventory (NPSI), rating of pain impact (daily activities, mood and sleep measured), patient global impression of change (PGIC), and use of paracetamol as escape medication. Secondary endpoints regarding mental function will be Trail Making Test A and B, rating of anxiety and depression (PROMIS), and rating of euforia. ;Timepoint(s) of evaluation of this end point: Secondary end points will be measured end of treatment week 8, or at baseline and end of treatment week 8 as appropriate.