At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 507 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.

Search/NCT01606137

NCT01606137Phase 3Completed

Compare CT.gov

A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.

Jazz Pharmaceuticals·interventional·Posted May 25, 2012·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating GW-1000-02 for Multiple Sclerosis and 2 related conditions. Completed, enrolled 507 participants across 1 site.

Detailed Summary

Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Sclerosis, Spasticity, Pain

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2002

Primary CompletionDec 2004

First PostedMay 2012

TodayJul 2026

First PostedMay 25, 2012

Enrollment StartFeb 1, 2002

Primary CompletionDec 1, 2004

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 14.1 years ago

Interventions

GW-1000-02drug

Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.