Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia

摘要: The aim of this study was to evaluate the efficacy and safety intramuscular (IM) administration botulinum toxin type A (Dysport, Ipsen Biopharm Ltd.) for treatment cervical dystonia (CD) long-term repeated treatments. During randomized, double-blind, placebocontrolled phase patients were randomized 500 units Dysport (n ¼ 55) or placebo 61). Efficacy assessments included Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total subscale scores, visual analogue scale (VAS) pain, subject/investigator’s VAS symptom assessments. Patients completing double-blind could enter an open-label extension receive up 4 additional produced a significant decrease from baseline in mean (� SE) TWSTRS scores compared with at Week (primary endpoint; � 15.6 2.0 vs. 6.7 2.0; p < 0.001) improvements sustained 12 (p 0.019). also pain placebo. duration participation 51.9 weeks (range 3.9e94.0 weeks). treatment, all cycles resulted post-treatment; greatest improvement seen cycle 1. between 15e17 weeks. demonstrated good profile; most adverse events mild moderate typical known profile indication. These results confirm that (500 units) is safe, effective, well-tolerated CD.