A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of post-herpetic neuralgia.

GW Pharma Ltd0 sites218 target enrollmentNovember 22, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2006

End Date

TBD

Last Updated

8 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:·
•\-Subjects aged 18 years or above.·
•\-Diagnosed with post\-herpetic neuralgia, of at least three months duration since rash healing, in whom pain is not wholly relieved with their current therapy. ·
•\-Subject has at least moderate pain (due to PHN), 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\.
•\-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 PHN.
•Previously tried and failed or could not tolerate analgesic therapy for their PHN.
•\-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.
•\-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.
•\-Subject is willing to maintain a stable dose of medications that may have an effect on neuropathic pain, other than study medication and paracetamol/acetaminophen, for the duration of the study.

•The subject may not enter the study if ANY of the following apply:·
•\-Subjects, whose identified pain is likely to be of a nociceptive, musculoskeletal, central neuropathic or psychogenic origin.
•\-Other pain, which is not of a peripheral neuropathic origin thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of PHN.
•\-Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study.
•\-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.
•\-Any known or suspected history of:\- or family history of schizophrenia, other psychotic illness\- alcohol or substance abuse\- epilepsy or recurrent seizures\- hypersensitivity to cannabinoids·
•\-Significant cardiac, renal or hepatic impairment.
•\-If female, is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
•\-Travel outside the country of residence planned during the study.
•\-Subjects who have received an Investigational Medicinal Product within the 12 weeks before the screening visit.