Article

OBJECTIVE: To investigate the efficacy and safety of repeated treatment with
incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins;
NT 201) in post-stroke upper limb spasticity. After
completing a double-blind, placebo- controlled, multicentre study (up to 20
weeks), 145 patients received up to 5 additional sets of NT 201 injections for an
open-label extension period of up to 69 weeks. METHODS: Upper limb muscle groups
were treated as clinically indicated; injection intervals were >/= 12 weeks.
Outcome was assessed 4 weeks after each injection session and at the end of the
study. RESULTS: Muscle tone (flexors of wrist, elbow, finger, and thumb, and
forearm pronators) improved throughout the study (response rate: up to 80.6%, p <
0.0001, Ashworth Scale). Continuous and significant improvements were also
observed in disability (p < 0.05, Disability Assessment Scale). The majority of
investigators, patients and caregivers rated NT 201 efficacy as very good or good
(56-84%). Adverse events considered treatment-related occurred in 11% of
patients. Formation of neutralizing antibodies was not observed in any patient
after repeated treatments. CONCLUSION: Treatment with NT 201 showed sustained
improvements in muscle tone and functionality (median dose 400 units) over a
study duration of up to 89 weeks, and was well tolerated during repeated
treatments for post-stroke upper limb spasticity.

Langue : ANGLAIS