Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Sympt… (NCT00702468) | Clinical Trial Compass
CompletedPhase 3
Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis
United Kingdom36 participantsStarted 2007-11
Plain-language summary
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with 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 MS.
* Received Sativex 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.
* Judged to have been receiving benefit from and shown tolerability to Sativex, in the investigators' and subjects' opinion.
* Takes a minimum dose of Sativex of two sprays per day.
* If receiving disease-modifying medications, these must have been at a stable dose for at least three months prior to screening, and willing to maintain this for the duration of the study.
* 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 willing to maintain this for the duration of the study (N.B. This should be 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.
* Willing for his or her name to be notified to the responsible authorities for participation in this study
Exclusion Criteria:
* Has any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level o…
What they're measuring
1
Number of Subjects Who Experience Treatment Failure.