Central neuropathic pain and spasticity MedDRA version: 20.0 Level: PT Classification code 10028335 Term: Muscle spasticity System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10077975 Term: Central neuropathic pain System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
Pharmaceutical Form: Capsule
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Other descriptive name: CBD
Concentration unit: mg milligr
Sponsors
Aarhus Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Probable or definite neuropathic pain in more than three months with a mean baseline pain intensity NRS >3 and 3. 2) Stable disease (MS and SCI) 3) Age = 18 years 4) Written Informed consent 5) Reliable contraception for fertile women 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 368 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1) Other pain conditions (e.g. diabetic neuropathy), which cannot be distinguished from central pain in MS and/or SCI 2) Current treatment with opioids 3) Severe Psychiatric disorder in patient or biological family (except well-treated depression) 4) History of suicidal 5) Pregnant or lactating women 6) Significant impairment of liver or kidney. 7) History of severe cardiovascular disease 8) History of seizures or epilepsy 9) Active Cancer disease 10) Abuse of cannabinoids, alcohol or medication. 11) There should not be use of cannabinoids 3 months before the study or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on central neuropathic pain and spasticity in patients with multiple sclerosis and in patients with spinal cord injury;Secondary Objective: To evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on the quality of life, cognition, stress, sleep, ataxia, and to explore the side effects. We also want to study the Pharmacodynamic and pharmacokinetic of the study medications. ;Primary end point(s): 1) Mean pain intensity during the last week of active treatment compared with baseline (Diary, Numeric Rating Scale (NRS)). 2) Mean severity of spasticity during the last week of active treatment compared with baseline (Diary, NRS 0-10). ;Timepoint(s) of evaluation of this end point: Mean pain intensity and mean spasticity score are evaluated during the last week of treatment (week 6) (from the patient diary). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Patient Global Impression of Change (PGIC) 2) Quality of life (EQ-5D) 3) Farmakodynamic /kinetic: Cmax, Cmin, Cave, AUC0-24, Tmax, Tmin ;Timepoint(s) of evaluation of this end point: PGIC and EQ-5D: At last visit (visit 4) in the last week in stable treatment (week 6) Farmacodynamic/kinetic are evaluated in 24 hours in the stable period of treatment (week 3-6) | — |
Countries
Denmark
Contacts
Public ContactNeurologi
Aarhus Universitetshospital
Outcome results
None listed