135
Participants
Start Date
August 31, 2002
Primary Completion Date
October 31, 2005
Study Completion Date
October 31, 2005
Sativex®
"Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L.~Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours"
Placebo
containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.
Division of Clinical Neurology, Queen's Medical Centre, Nottingham
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY