NCT01610700

An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Detailed description

Eligible subjects entered a one to two week baseline period; followed by a six week double blind, randomised, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. Existing medication continued at a constant dose. Primary efficacy comparisons were made between symptom scores recorded during baseline and scores recorded at the end of the parallel group period.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	GW-1000-02	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.
DRUG	Placebo	Each actuation of placebo delivered the excipients only.

Timeline

• Start date: 2001-05-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2012-06-04
• Last updated: 2023-01-12
• Results posted: 2012-09-19

Locations

1 site across 1 country: United Kingdom