A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A

GW Pharma Ltd0 sites284 target enrollmentFebruary 4, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 4, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Subject is willing and able to give informed consent for participation in the study
•2\. Aged 18 years or above
•3\. Subject is able (in the investigators opinion) and willing to comply with all study requirements
•4\. Diagnosed with any disease sub\-type of MS of duration of greater than 6 months
•5\. Diagnosed with spasticity due to MS of at least 3 months duration and whose spasticity is not wholly relieved with their current therapy
•6\. If receiving disease modifying medications, these be at a stable dose for at least six months duration prior to the screening visit and willing to maintain this for the duration of the study
•7\. If receiving regular anti\-spasticity and non\-pharmacological therapies, these be at a stable dose for at least 30 days prior to the screening visit and willing for these to be maintained throughout the study
•8\. The last 6 daily spasticity NRS scores before randomisation (B2 to B7\) have been completed and to sum at least 24
•9\. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
•10\. Willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study

•1\. Any concomitant disease or disorder that has symptoms of spasticity, or that may influence the subject's level of spasticity
•2\. Currently receiving Botulinum Toxin injections and unwilling to stop for the duration of the study, or has received Botulinum Toxin injection within 4 months prior to the screening visit
•3\. Currently using or has used cannabis within 30 days of study entry and unwilling to abstain for the duration of the study
•4\. Currently using or has used cannabinoid based medications within 60 days of study entry and unwilling to abstain for the durationof the study
•5\. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
•6\. Any known history of alcohol or substance abuse
•7\. Any history of epilepsy or recurrent seizures
•8\. Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications
•9\. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
•10\. Subject has a QT interval \> 450 ms (males) or \> 470 ms (females) as reviewed at the screening visit