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

March 1, 2016 updated by: Daewoong Pharmaceutical Co. LTD.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin type A (DWP450)
DWP450: Botulinum toxin type A
Drug: Botulinum toxin type A
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®)
Active Comparator: Botulinum toxin type A (Botox®)
Botox®: Botulinum toxin type A
Drug: Botulinum toxin type A
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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP450002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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