NCT01392300

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Detailed description

The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Conditions

• Post-stroke Spasticity of the Upper Limb

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (400 Units)	Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection
DRUG	Placebo Comparator	Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-03-01
• Completion: 2014-02-01
• First posted: 2011-07-12
• Last updated: 2017-01-16
• Results posted: 2016-02-11

Locations

47 sites across 7 countries: United States, Czechia, Germany, Hungary, India, Poland, Russia