At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 137 enrolled
Drug / intervention
GW-1000-02drug
Likely dose
GW-1000-02 2.7 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 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 and Spasticity. Completed, enrolled 137 participants across 1 site.
Detailed Summary
An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Spasticity
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2001
Primary CompletionFeb 2005
First PostedJun 2012
TodayJul 2026
First PostedJun 4, 2012
Enrollment StartJul 1, 2001
Primary CompletionFeb 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.1 years ago
Interventions
GW-1000-02drug
Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose 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.