Peripheral neuropathic pain due to polyneuropathy, postherpetic neuralgia, or peripheral nerve injury (surgical or traumatic). MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Product Name: Dronabinol capsule 2,5 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Contacts
Public ContactNeuromuscular team
Odense University Hospital
Outcome results
None listed