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.
- Conditions
- Post-herpetic neuralgia symptom relief.
- Registration Number
- EUCTR2006-003655-20-GB
- Lead Sponsor
- GW Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 218
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the analgesic efficacy of Sativex® compared with placebo, when added to existing treatment regimens, in relieving post-herpetic neuralgia (PHN). ;Secondary Objective: To evaluate the effect of Sativex® compared with placebo on:·<br>Secondary measures of pain relief<br>Brief Pain Inventory (BPI)<br>Subject Global Impression of Change<br>Sleep quality <br><br>To assess the safety and tolerability of Sativex®;Primary end point(s): The primary endpoint is the mean pain (due to PHN) numeric rating scale (NRS) score at the end of treatment (usually week 14). The variable for analysis will be the change in mean NRS from baseline to the end of the treatment.
- Secondary Outcome Measures
Name Time Method