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 3CompletedNCT01945684

Daewoong Pharmaceutical Co. LTD.197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

197

Conditions

Spasticity Stroke

Interventions

Botulinum toxin type ADRUG

Maximum dose 360 U

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu

Seoul, South Korea

Outcomes

Primary Outcomes

The change in MAS(Modified Ashworth Scale)grade for Wrist flexor

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

Time frame: at 4 week

Data from ClinicalTrials.gov

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