NCT01945684

A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.

Conditions

• Spasticity
• Stroke

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Maximum dose 360 U

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2013-09-18
• Last updated: 2016-03-03

Locations

1 site across 1 country: South Korea