Multiple Sclerosis
Conditions
Interventions
Product Name: Cannador
Pharmaceutical Form: Capsule, soft
Current Sponsor code: Standardised Cannabis Extract
Concentration unit: mg milligram(s)
Sponsors
Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research)
WELEDA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed informed consent. -Diagnosis of MS according to McDonald criteria. -Current muscle stiffness =4 on a 11-point categorical rating scale. -On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial. -Stable disease for the previous 6 months in the opinion of the treating physician. -Antispasticity medication and physiotherapy stabilised for the last 30 days. -Patients may be ambulatory or not. -Age 18-64. 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days -Past or present history of psychotic illness. -Open / infected pressure sores or other source of chronic infection. -Significant fixed tendon contractures. -Severe cognitive impairment such that the patient is unable to provide informed consent. -History of clinically important renal, cardiovascular or neurol. diseases (apart from MS). -Malignancy within the past 2 years. -Cannabinoids taken currently or in previous 30 days. -Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.) -Known hypersensitivity to cannabinoids. -Current drug abuse, including alcohol abuse. -Laboratory parameters outside the following limits: Creatinine > 3x upper limit of normal Bilirubine > 3x upper limit of normal Transaminases > 5 x upper limit of normal -Anticipated immunisations within the 12 weeks of trial participation. -Other problems likely to make participation difficult at the discretion of the neurologist. -Women who are pregnant, lactating or not using adequate contraception. -Participation in other treatment studies currently or within the previous month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of a standardised oral extract of Cannabis sativa compared to placebo on the relief of muscle stiffness (11-point Likert scale).; Secondary Objective: To determine effect of standardised extract of cannabis sativa (using 11-point Likert scale) on relief of body pain, amount of muscle stiffness, amount of body pain, relief and amount of spasms, relief and amount of sleep disturbances, disease-specific impact on life (Multiple Sclerosis Spasticity Scale [MSSS]-88 and Multiple Sclerosis Impact Scale [MSIS]-29), patient-rated ability to walk (Multiple Sclerosis Walking Scale [MSWS]-12). To determine the safety of standardised cannabis extract of cannabis sativa in treatment of multiple sclerosis for a preiod of 12 weeks ; Primary end point(s): The primary efficacy variable is the change in muscle stiffness after a 12-weeks treatment compared to baseline. At the visit after twelve weeks of treatment patients will answer the following question using a categorical rating scale: “Compared with before the study started, my muscle stiffness over the last week has been…” This will be rated by the patient on a 11-point numerical Likert scale with 0 = very much better and 10 = very much worse; 5 = no difference. | — |
Countries
United Kingdom
Outcome results
None listed