Spasticity in multiple sclerosis (MS). MedDRA version: 14.1 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
Conditions
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: Subjects meeting the following criteria will be considered eligible for this study. • Subject is aged 18 years or above. • Diagnosed with any disease sub-type of MS. • Diagnosed with symptomatic spasticity due to MS. • Subject has at least moderate spasticity in the opinion of the investigator. • Subject fulfils at least one of the two criteria below. Subject must be either: • Currently established on a regular dose of anti-spasticity therapy, or • Previously tried and failed anti-spasticity therapy. • Stable medication regimen for at least 4 weeks prior to study entry, for all medications which may have an effect on spasticity and/or cognition. • If the subject is taking disease modifying medication this must be at a stable dose for 3 months prior to initial visit. • Willing and able to give informed consent. • Willing and able to comply with all study requirements. • Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable. • Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Exclusion: The subject may not enter the study if ANY of the following apply: • Any history or immediate family of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. • Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures) that may influence the subject’s level of cognition or mood. • Currently using or has used cannabis or cannabinoid-based medications within 30 days of study entry and unwilling to abstain for the duration of the study. • Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption (more than 60g of pure alcohol per day [equivalent to a bottle of wine (0.75l) or five glasses of lager (1.5l) or four double liquors] for men, and more than 40g of pure alcohol per day [equivalent of two-thirds of that stated for men] for women), current use of an illicit drug or current non-prescribed use of any prescription drug. • Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP)(s). • Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. • Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. • Subjects who have received an IMP within the 12 weeks prior to the initial visit. • Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject’s ability to participate in the study. • Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator would prevent the subject from safe participation in the study. • Subjects previously randomised into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in cognitive performance and psychological status of patients with spasticity due to MS when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks.;Secondary Objective: To evaluate the effect of Sativex on mood and spasticity To assess the safety and tolerability of Sativex.;Primary end point(s): The primary endpoint is the change in cognitive function as assessed by the total Paced Auditory Serial Addition Test (PASAT I and II) score from baseline (Visit 1) to end of treatment visit (Visit 5 Day 337 or withdrawal date).;Timepoint(s) of evaluation of this end point: Visits 1, 2, 3, 4, & 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of Sativex compared with placebo on: • Mood as assessed by the BDI-II2 • Subject Global Impression of Change in severity of spasticity • Caregiver Global Impression of Change in severity of spasticity • Physician Global Impression of Change in severity of spasticity • Modified Ashworth Scale score • Timed 10-metre walk To assess the safety and tolerability of Sativex: • Adverse Events • Clinical Laboratory Tests • Vital signs • Suicidal tendencies as assessed by the Colombia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: All end points will be evaluated on visits 1,2,3,4 & 5 apart from the following: • Clinical Laboratory tests will be evaluated at visit 1, 3 and 5 only. • Adverse Events will be evaluated at all visits (1-6) • Number of Visits to a Healthcare Professional • Suicidal Tendencies as Assessed by the Columbia-Suicide Severity Rating Scale | — |
Countries
Czech Republic
Contacts
Public ContactGW Pharma Ltd. Switchboard
GW Pharma Ltd.
Outcome results
None listed