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NCT01945684 Clinical 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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01945684
Other study ID # DW_DWP450002
Secondary ID
Status Completed
Phase Phase 3
First received September 16, 2013
Last updated March 1, 2016
Start date September 2013
Est. completion date July 2014

Study information
Verified date March 2016
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date July 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum toxin type A
Maximum dose 360 U

Locations
Country Name City State
Korea, Republic of SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 at 4 week No
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