A double blind, randomised, placebo controlled, parallel group study of Sativex, in the treatment of subjects with peripheral neuropathic pain associated with allodynia - N/a

GW Pharma Ltd0 sites218 target enrollmentAugust 28, 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GW Pharma Ltd
Enrollment: 218
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 28, 2006

End Date

October 18, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GW Pharma Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Subject is willing and able to give informed consent for participation in the study
•2\. Male or female, aged 18 years or above
•3\. Subject is able (in the investigators opinion) and willing to comply with all study requirements
•4\. Diagnosed with peripheral neuropathic pain of at least 6 months duration and in who pain is not wholly relieved with their current therapy
•5\. Subject must have presence of mechanical allodynia within the territory of the affected nerve(s). This should be confirmed by a positive pain response to either stroking the allodynic area with a SENSELAB brush 05 or to force applied by a 5\.07 gram Semmes\-Weinstein monofilament.
•6\. Subject must have at least one of the following underlying conditions, which causes their peripheral neuropathic pain;
•\- postherpetic neuralgia, peripheral neuropathy, focal nerve lesion, or complex regional pain syndrome (CRPS) type 2\. Note: CRPS type 1 is excluded
•7\. Stable dose of regular pain medication and non\-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willing for these to be maintained throughout the study. Where patients are taking a medication containing paracetamol please refer to section 8\.3
•8\. Has the subject, in the opinion of the investigator, received or is currently receiving the appropriate peripheral neuropathic pain treatments for their condition
•9\. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries

Exclusion Criteria

•1\. Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their peripheral neuropathic pain
•2\. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study
•3\. CRPS type 1, cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
•4\. Subjects who haveused within the last year, or who are currently using, either cannabis (either for recreational or medical purposes) or cannabis based medicines and who are unwilling to abstain for the duration of 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 or suspected history of alcohol or substance abuse
•7\. Any history of epilepsy or recurrent seizures
•8\. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
•9\. Subject has evidence of cardiomyopathy
•10\. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction withinthe 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