A Study of the Long-term Safety of Sativex Use

Phase 3 Completed 507 enrolled Jazz Pharmaceuticals

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2002-02
Primary completion: 2004-12
Completion: 2004-12

Publications

Results Serpell MG, Notcutt W, Collin C. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis. J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	2.5 mg	Other
Subject	delta-9-tetrahydrocannabinol	Other / unclassified	2.7 mg	Other

A Study of the Long-term Safety of Sativex Use

Summary

Timeline

Publications

Drugs

Indications