NCT01599234 - A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis | Biotech Hunter

Enrollment

337

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

December 31, 2005

Study Completion Date

December 31, 2005

Conditions

Multiple Sclerosis

Interventions

DRUG

Sativex

Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours.

DRUG

Placebo

Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.

Trial Locations (1)

RG1 5AN

The Royal Berkshire and Battle Hospitals NHS Trust, Reading