Overview

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
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
Inclusion Criteria:

1. Male or female adult patients

2. ≥ 6 weeks since the last stroke

Exclusion Criteria:

1.Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia
gravis, or amyotrophic lateral sclerosis.