Primary Outcome Measures:
- The weekly pain severity on a 0-10 NRS score compared monthly to titration score and pre-treatment score. [ Time Frame: Month 1 to last Month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neuropathic Pain Score [ Time Frame: Weeks 2,14 & 26 ] [ Designated as safety issue: No ]
- sleep quality 0-10 NRS [ Time Frame: Weeks 2,14 & 26 ] [ Designated as safety issue: No ]
- subject global impression of change [ Time Frame: Last Visit ] [ Designated as safety issue: No ]
- Health Questionnaires [ Time Frame: Last Visit ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests. [ Time Frame: Week 58 ] [ Designated as safety issue: Yes ]
- Vital signs. [ Time Frame: week 2, 14, 26 and 38 ] [ Designated as safety issue: Yes ]
- Oral Examination. [ Time Frame: week 2, 14, 26 and 38 ] [ Designated as safety issue: Yes ]
- intoxication 0-10 NRS [ Time Frame: Week 2, 14 & 26 ] [ Designated as safety issue: Yes ]
This was a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. The study provided continued availability of Sativex® to subjects who completed the preceding double-blind neuropathic pain studies. Consenting, eligible subjects who had participated in previous GW Pharma Ltd (GW) randomised, placebo-controlled clinical studies entered the study (Visit 1, Day 0) and commenced dosing. Study visits took place at Week 2 (Visit 2, Day 14), Week 14 (Visit 3, Day 98), and Week 26 (Visit 4, Day 182). Subjects returned to the centre for an end of treatment visit at week 38 (Visit 5, Day 266). All subjects received Sativex®. This was followed by a five week randomised-withdrawal phase (Part B) for a subset of subjects. An end of study visit took place 28 days after Visit 5 (or 5b or 5c) or withdrawal from the study.