A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)

PHASE3CompletedINTERVENTIONAL
Enrollment

572

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
SpasticityMultiple Sclerosis
Interventions
DRUG

Sativex®

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg)

DRUG

Placebo

containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).

Trial Locations (1)

NN1 5BD

Department of Neurology, Northampton General Hospital, Cliftonville

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY