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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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT01945684
Collaborator
(none)
197
Enrollment
1
Location
2
Arms
10
Duration (Months)
19.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin type A
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
197 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

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®)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change in MAS(Modified Ashworth Scale)grade for Wrist flexor [at 4 week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu Seoul Korea, Republic of 156-707

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT01945684
    Other Study ID Numbers:
    • DW_DWP450002
    First Posted:
    Sep 18, 2013
    Last Update Posted:
    Mar 3, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Muscle Spasticity
    Stroke
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Mar 3, 2016