NCT01868048

Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.

A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GW Research Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis.

Conditions

• Spasticity
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Sativex	Contains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Subjects receive study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.
DRUG	Placebo	Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day.

Timeline

• Primary completion: 2017-06-01
• First posted: 2013-06-04
• Last updated: 2016-08-11