E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 22 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as the last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |