Journal of Multiple Sclerosis
ISSN - 2376-0389NLM - 101654564
Jan Mares
Czech Republic
Research Article
A Multicentre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Study of Effect of Long-Term Sativex® Treatment on Cognition and Mood of Patients with Spasticity Due to Multiple Sclerosis
Author(s): Marta Vachová, Alena Novotná, Jan Mares, Radomír Taláb, Jirí Fiedler, Heather Lauder, Lesley Taylor, Tilden Etges, Stephen Wright and Iveta NovákováMarta Vachová, Alena Novotná, Jan Mares, Radomír Taláb, Jirí Fiedler, Heather Lauder, Lesley Taylor, Tilden Etges, Stephen Wright and Iveta Nováková
Objective: When Sativex ®THC:CBD cannabinoid-based oromucosal spray was first approved as a prescription medicine for multiple sclerosis (MS) spasticity, there was some concern about its possible long-term impact on cognition and mood. The objective of this study was therefore to assess the long-term impact of Sativex on cognitive function and mood in MS patients with spasticity.
Methods: 121 patients were randomly assigned Sativex or placebo in a double-blind manner. Patients self-administered treatment daily for 48 weeks while maintaining anti-spasticity therapy. The primary endpoint was the difference between treatments in Paced Auditory Serial Addition Test (PASAT) score from baseline to end of treatment. Secondary measures included Beck Depression Inventory-II (BDI-II), Subject-, Physician- and Caregiver Global Impression of Change, .. View More»
DOI: 10.4172/jmso.1000122
