A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in … (NCT00681538) | Clinical Trial Compass
CompletedPhase 3
A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)
United Kingdom572 participantsStarted 2008-01
Plain-language summary
The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to give written informed consent for participation in the study.
* Male or female, aged 18 years or above.
* Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
* Diagnosed with any disease sub-type of MS of at least six months duration.
* Spasticity due to MS of at least three months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
* 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, or could not tolerate suitable anti-spasticity therapy.
* Subject is currently receiving a stable regimen (for at least 30 days prior to study entry) of all medications that may have an effect on spasticity; and willing to maintain this for the duration of the study. If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
* Willing for his or her name to be notified to his or her primary care physician, and consultant and the responsible authorities for participation in this study, as applicable.
Exclusion Criteria:
* Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of…
What they're measuring
1
The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).
Timeframe: Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)