An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

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.

Timeline

Start

2001-05

Primary completion

2002-07

Completion

2002-07

Outcome

Missed primary endpoint

paper primary symptom score reduced from mean (SE) 74.36 (11.1) to 48.89 (22.0) following CBME and from 74.31 (12.5) to 54.79 (26.3) following placebo [ns]. PMID 15327042 ↗

release “The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21” jazzpharma.com ↗

Publications

• Results Wade DT, Makela P, Robson P, House H, Bateman C. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult Scler. 2004 Aug;10(4):434-41. doi: 10.1191/1352458504ms1082oa.
• Di Marzo V, Centonze D. Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes. CNS Neurosci Ther. 2015 Mar;21(3):215-21. doi: 10.1111/cns.12358. Epub 2014 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	20 mg	Other
Subject	Cannabidiol	Other / unclassified	25 mg/ml	Other
Subject	Cannabidiol	Other / unclassified	120 mg	Other
Subject	delta-9-tetrahydrocannabinol	Other / unclassified	22 mg	Other
Subject	delta-9-tetrahydrocannabinol	Other / unclassified	27 mg/ml	Other
Subject	delta-9-tetrahydrocannabinol	Other / unclassified	130 mg	Other

Indications