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

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