CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
GW-1000-02 +1 moredrug
Likely dose
GW-1000-02 2.5 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.

Search/NCT01606176
NCT01606176Phase 3Completed
CompareCT.gov

A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.

Jazz Pharmaceuticals·interventional·Posted May 25, 2012·Updated Jan 10, 2023

In Brief

A Phase 3 clinical trial evaluating GW-1000-02 and Placebo for Pain and Multiple Sclerosis. Completed, enrolled 70 participants across 1 site.

Detailed Summary

To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Multiple Sclerosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2012
Enrollment StartMar 1, 2002
Primary CompletionAug 1, 2002
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.1 years ago

Interventions

GW-1000-02drug

Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).

Placebodrug

Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.