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

Phase 3

Completed

• Conditions: Spasticity; Stroke
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT01945684
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-18
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A (Botox®)	Botulinum toxin type A	Botox®: Botulinum toxin type A
Botulinum toxin type A (DWP450)	Botulinum toxin type A	DWP450: Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
The change in MAS(Modified Ashworth Scale)grade for Wrist flexor	at 4 week	The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone

Trial Locations

Locations (1)

SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu; 🇰🇷 Seoul, Korea, Republic of