At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 154 enrolled
Drug / intervention
GW-1000-02drug
Likely dose
GW-1000-02 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.
Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension
In Brief
A Phase 3 clinical trial evaluating GW-1000-02 for Multiple Sclerosis. Completed, enrolled 154 participants across 1 site.
Detailed Summary
An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2001
Primary CompletionJul 2002
First PostedJun 2012
TodayJul 2026
First PostedJun 4, 2012
Enrollment StartMay 1, 2001
Primary CompletionJul 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago
Interventions
GW-1000-02drug
Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.