The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury

INTERVENTION: 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 milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Dronabinol capsule 2,5 mg Product Code: N/A Pharmaceutical Form: Capsule INN or Proposed INN: DRONABINOL CAS Number: 1972‐08‐3 Other descriptive name: THC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A Pharmaceutical Form: Capsule INN or Proposed INN: DRONABINOL CAS Number: 1972‐08‐3 Other descriptive name: THC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ INN or Proposed INN: Cannabidiol CAS Number: 13956‐29‐1 Other descriptive name: CBD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: 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 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: 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 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).; ; 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.; 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 OUTCOME: 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) INCLUSION CRITERIA: 1) Probable or definite neuropathic pain in more than three months with a mean baseline pain intensity NRS >3 and < 9 and/or spasticity severity NRS > 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 448 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range