Symptoms of spasticity in multiple sclerosis.
Conditions
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting the following criteria will be considered eligible for this study: - Aged 18 years or above. - Subject is able (in the investigator’s opinion) and willing to comply with all study requirements. - Subject has a diagnosis of MS. - Subject has received GW-1000-02 for the relief of spasticity for at least 12 weeks prior to screening and willing to stop dosing with their own supply for the duration of the study. - Subject is judged to have been receiving benefit from and shown tolerability to GW-1000-02, in both the investigators’ and subjects’ opinion. - Subject is currently taking a minimum dose of GW-1000-02 of two sprays per day. - If the subject is receiving disease-modifying medications, these must be at a stable dose for at least three months prior to screening, and the subject must be willing to maintain these for the duration of the study. - Subject has had a stable regimen for at least 30 days prior to study entry, for all medications and non-pharmacological therapies that may have an affect on spasticity and are willing to maintain these for the duration of the study (N.B., This should be for at least three months prior to study entry, in the case of Interferon therapy. - Willing to allow his or her general 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: 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The subject may not enter the study if ANY of the following apply: - Subject has any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject’s level of spasticity. - Subject is unable to rate their level of spasticity or distinguish their level of spasticity from other MS symptoms. - Subject has any known or suspected family history of schizophrenia or other psychotic illness. - Subject has significant cardiac, renal or hepatic impairment. - 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 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 before the screening visit. - Travel outside the UK planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the maintenance of effect of GW-1000-02 [named Sativex® in Canada and also named Sativex® Oromucosal Spray] compared with placebo in relieving symptoms of spasticity due to MS, in subjects who have been receiving long-term benefit from GW-1000-02.;Secondary Objective: To investigate the effect of GW-1000-02 withdrawal compared with placebo on: • Secondary measures of spasticity • Functional measures of spasticity • Sleep quality (disruption) To assess the safety and tolerability of GW-1000-02 withdrawal. ;Primary end point(s): The primary endpoint is the time to treatment failure in the randomised-withdrawal period. | — |
Countries
United Kingdom
Outcome results
None listed