A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

August 31, 2002

Study Completion Date

August 31, 2002

Conditions
Multiple SclerosisNeuropathic Pain
Interventions
DRUG

Placebo

Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

DRUG

Sativex

Contained delta-9-tetrahydrocannabinol (THC), (25 mg/ml):cannabidiol (CBD), (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

Trial Locations (1)

L9 7LJ

Walton Centre for Neurology and Neurosurgery, Liverpool

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY