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

摘要: Background:  Spasticity is a disabling complication of multiple sclerosis, affecting many patients with the condition. We report first Phase 3 placebo-controlled study an oral antispasticity agent to use enriched design. Methods:  A 19-week follow-up, multicentre, double-blind, randomized, placebo-controlled, parallel-group in subjects sclerosis spasticity not fully relieved current therapy. Subjects were treated nabiximols, as add-on therapy, single-blind manner for 4 weeks, after which those achieving improvement ≥20% progressed 12-week phase. Results:  Of 572 enrolled, 272 achieved 4 weeks treatment, and 241 randomized. The primary end-point was difference between treatments mean Numeric Rating Scale (NRS) controlled phase study. Intention-to-treat (ITT) analysis showed highly significant favour nabiximols (P = 0.0002). Secondary end-points responder analysis, Spasm Frequency Score, Sleep Disturbance NRS Patient, Carer Clinician Global Impression Change all nabiximols. Conclusions:  design provides method determining efficacy safety way that more closely reflects proposed clinical practice, by limiting exposure who are likely benefit from it. Hence, active placebo should be reflection population intended treatment.