NCT01538225

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Sativex®	THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients. Duration: 2 weeks
DRUG	Placebo	Placebo Same frequency and dosage form as Sativex. Duration: 2 weeks

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-24
• Last updated: 2014-01-20

Locations

1 site across 1 country: Italy