Back to resultsA 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
Primary Purpose
Spasticity, Stroke
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Spasticity
Eligibility Criteria
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.
Sites / Locations
- SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulinum toxin type A (DWP450)
Botulinum toxin type A (Botox®)
Arm Description
DWP450: Botulinum toxin type A
Botox®: Botulinum toxin type A
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01945684
First Posted
September 16, 2013
Last Updated
March 1, 2016
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT01945684
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin type A (DWP450)
Arm Type
Experimental
Arm Description
DWP450: Botulinum toxin type A
Arm Title
Botulinum toxin type A (Botox®)
Arm Type
Active Comparator
Arm Description
Botox®: Botulinum toxin type A
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
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®)
Intervention Description
Maximum dose 360 U
Primary Outcome Measure Information:
Title
The change in MAS(Modified Ashworth Scale)grade for Wrist flexor
Description
The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone
Time Frame
at 4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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