NCT01464307

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg 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 Lower Limb

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (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 leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Conditions

• Post-stroke Spasticity of the Lower 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: 2011-12-01
• Primary completion: 2014-08-01
• Completion: 2015-05-01
• First posted: 2011-11-03
• Last updated: 2016-11-07
• Results posted: 2016-11-07

Locations

53 sites across 9 countries: United States, Canada, Czechia, France, Germany, Italy, Poland, Russia, Spain