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Research Library

A-Z Conditions  Participate in ORR

A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis

  • Journal : European Journal of Neurology
  • Publication Year : 2011
  • Authors : A. Novotna, J. Mares, S. Ratcliffe, I. Novakova, M. Vachova, O. Zapletalova, C. Gasperini, C. Pozzilli, L. Cefaro, G. Comii, P. Rossii, Z. Ambler, Z. Stelmasiak, A. Erdmann, X. Montalban, A. Klimek, & P. Davies

Background: Spasticity is a disabling complication of multiple sclerosis, affecting many patients with the condition. We report the first Phase 3 placebo-controlled study of an oral antispasticity agent to use an enriched study design.

Methods: A 19-week follow-up, multicentre, double-blind, randomized, placebo-controlled, parallel-group study in subjects with multiple sclerosis spasticity not fully relieved with current antispasticity therapy, Subjects were treated with nabiximols, as add-on therapy, in a single-blind manner for 4 weeks, after which those achieving an improvement in spasticity of 20% progressed to a 12-week randomized, placebo controlled phase.

Results: Of the 572 subjects enrolled, 272 achieved a 20% improvement after 4 weeks of single-blind treatment, and 241 were randomized. The primary end-point was the difference between treatments in the mean spasticity Numeric Rating Scale (NRS) in the randomized, controlled phase of the study. Intention-to-treat (ITT) analysis showed a highly significant difference in favour of nabiximols (P 0.0002). Secondary end-points of responder analysis, Spasm Frequency Score, Sleep Disturbance NRS Patient, Carer and Clinician Global Impression of Change were all significant in favour of nabiximols. Conclusions: The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice, by limiting exposure to those patients who are likely to benefit from it. Hence, the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment.

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Conditions:

  • Multiple Sclerosis, Spasticity

Research Information:

Research Keywords:

  • ∆9-tetrahydrocannabinol (THC), Cannabidiol (CBD), Cannabinoid/s, Endocannabinoid system, Multiple sclerosis (MS), Nabiximols, Sativex, spasticity

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