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

• Register: EUCTR
• Last refreshed on: 23 November 2020
• Main ID: EUCTR2018-002315-98-DK
• Date of registration: 09/07/2018
• Prospective Registration: Yes
• Primary sponsor: Aarhus Universitetshospital
• Public title: The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.
• Scientific title: The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI
• Date of first enrolment: 06/12/2018
• Target sample size: 448
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002315-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Neurologi
• Affiliation: Aarhus Universitetshospital

• Name: Neurologi
• Affiliation: Aarhus Universitetshospital

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

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

Primary Outcome(s)

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.

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).

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 Outcome(s)

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)

Secondary ID(s)

MedicalcannabisMSSCI2018

Source(s) of Monetary Support

Ministry of Health

Ethics review

Status: Approved
Approval date: 25/10/2018
Contact: