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

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.

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Key information

Conditions

Spasticity Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female adult patients
≥ 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.

Treatment and study plan

Botulinum Toxin Type A

Drug

Maximum dose 360 U

Other names: Assigned Interventions, Experimental: DWP450, Botulinum toxin type A Drug: Botulinum toxin type A, Active Comparator: Botox®, Botulinum Toxin type A Drug: Botulinum Toxin type A (Botox®)

Primary outcomes

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

Time frame: at 4 week

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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Sep 18, 2013
Registry last updated: Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed