NCT01945684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

September 16, 2013

Last Update Submit

March 1, 2016

Conditions

SpasticityStroke

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Botulinum toxin type A (DWP450)

EXPERIMENTAL

DWP450: Botulinum toxin type A

Drug: Botulinum toxin type A

Botulinum toxin type A (Botox®)

ACTIVE COMPARATOR

Botox®: Botulinum toxin type A

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type ADRUG

Maximum dose 360 U

Also known as: 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®)
Botulinum toxin type A (Botox®)Botulinum toxin type A (DWP450)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adult patients
  • ≥ 6 weeks since the last stroke

You may not qualify if:

  • Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Muscle SpasticityStroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 18, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

March 3, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)