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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

D

Daewoong Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Spasticity
Stroke

Treatments

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01945684
DW_DWP450002

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

197 participants in 2 patient groups

Botulinum toxin type A (DWP450)
Experimental group
Description:
DWP450: Botulinum toxin type A
Treatment:
Drug: Botulinum toxin type A
Botulinum toxin type A (Botox®)
Active Comparator group
Description:
Botox®: Botulinum toxin type A
Treatment:
Drug: Botulinum toxin type A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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