A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.

GW Pharma Ltd0 sites218 target enrollmentOctober 27, 2006

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2006

End Date

April 29, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects meeting the following criteria will be considered eligible for this study:
•1\. Subjects aged 18 years or above.
•2\. Diagnosed with any disease sub\-type of multiple sclerosis (MS) of at least two years duration.
•3\. Central neuropathic pain (CNP) due to MS, of at least three months and which is expected to remain stable for the duration of the study.
•4\. Subject has at least moderate CNP, which is defined by: NRS pain scores on all of baseline days B2 to B7 have been recorded, via the IVRS, by the subject and sum to at least 24\.
•5\. Subject fulfils at least one of the two criteria below. Subject must be either:
•\- Currently established on a regular dose of analgesic therapy for their CNP
•\- Previously tried and failed or could not tolerate analgesic therapy for their CNP.
•6\. Stable medication regimen for at least 2 weeks prior to study entry, for all medications that may have an affect on neuropathic pain, except paracetamol/acetaminophen.
•7\. Subject is willing to stop taking their own paracetamol/acetaminophen or paracetamol/acetaminophen containing medications and start using study medication paracetamol/acetaminophen as required (prn) for the duration of the study.

•The subject may not enter the study if ANY of the following apply:
•1\. Subjects whose identified pain is likely to be of a nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic origin, or is due to trigeminal neuralgia.
•2\. Other pain which is not of a central neuropathic origin thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of neuropathic pain due to MS.
•3\. Subjects medical history suggests that relapses/remission are likely to occur during the study (the next 15 weeks) which are expected to influence the subjects CNP.
•4\. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study.
•5\. Currently using or has used recreational cannabis, medicinal cannabis (including Sativex®), or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration for the study.
•6\. Any known or suspected history of:
•\- or family history of schizophrenia, other psychotic illness;
•\- alcohol or substance abuse
•\- epilepsy or recurrent seizures