At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 380 enrolled
Drug / intervention
Sativex®drug
Likely dose
Sativex® 27 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Open Label, Follow on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex® in the Treatment of Subjects With Neuropathic Pain. This Will be Followed by a Randomised-withdrawal Phase (Part B) for a Subset of Patients.
In Brief
A Phase 3 clinical trial evaluating Sativex® for Pain and Peripheral Neuropathy. Completed, enrolled 380 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Peripheral Neuropathy
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
Primary CompletionJun 2007
First PostedJul 2008
TodayJul 2026
First PostedJul 11, 2008
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.0 years ago
Interventions
Sativex®drug
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours