Efficacy and safety of treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity

• Published in: Journal of rehabilitation medicine 2011-05, Vol.43 (6), p.486-492
• Main Authors: Kaňovský, Petr, Slawek, Jaroslaw, Denes, Zoltan, Platz, Thomas, Comes, Georg, Grafe, Susanne, Pulte, Irena
• Format: Article
• Language: English
• Subjects: Adult; Aged; Arm - physiopathology; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - adverse effects; Botulinum Toxins, Type A - therapeutic use; Disability Evaluation; Double-Blind Method; Efficacy; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Muscle Spasticity - drug therapy; Muscle Spasticity - etiology; Muscles; Neuromuscular Agents - administration & dosage; Neuromuscular Agents - adverse effects; Neuromuscular Agents - therapeutic use; Prospective Studies; Safety; Spasticity; Stroke - complications; Stroke - physiopathology; Strokes; Time Factors; Toxins; Treatment Outcome; Upper limbs
• ISSN: 1650-1977; 1651-2081
• DOI: 10.2340/16501977-0796

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. 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. Muscle tone (flexors of wrist, elbow, finger, and thumb, and forearm pronators) improved throughout the study (response rate: up to 80.6%, p