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A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:
A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis

Clinical Trial Summary

A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.

Clinical Trial Description

Eligible patients entered this 50 week multicenter, double-blind, randomised, placebo-controlled, parallel group study which evaluated the effect of Sativex on cognitive performance. At each scheduled clinic visit, patients were assessed for cognitive performance, mood, severity of spasticity, use of investigational medicinal products and number of visits to a healthcare professional. Primary efficacy comparisons were made between scores recorded during baseline and scores recorded at the end of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01964547
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Completed
Phase Phase 4
Start date January 2012
Completion date May 2013
View Details
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