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

Phase 1

• Conditions: Central neuropathic pain and spasticity; MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10077975Term: Central neuropathic painSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002315-98-DK
• Lead Sponsor: Aarhus Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-09
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 448

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 368
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. <br>We also want to study the Pharmacodynamic and pharmacokinetic of the study medications.<br>;Primary end point(s): 1)Mean pain intensity during the last week of active treatment compared with baseline (Diary, Numeric Rating Scale (NRS)).<br>2)Mean severity of spasticity during the last week of active treatment compared with baseline (Diary, NRS 0-10).<br><br>;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).<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Patient Global Impression of Change (PGIC)<br>2) Quality of life (EQ-5D) <br>3) Farmakodynamic /kinetic: Cmax, Cmin, Cave, AUC0-24, Tmax, Tmin<br>;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)<br><br>Farmacodynamic/kinetic are evaluated in 24 hours in the stable period of treatment (week 3-6)