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Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity

NCT01915459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2015-05-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.

Conditions

Interventions

BIOLOGICAL

Botulinum toxin type A(Botulax®)

IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone

BIOLOGICAL

Botulinum toxin type A(Botox®)

Sponsors & Collaborators

  • Hugel

    lead INDUSTRY

Principal Investigators

  • Min-ho Chun, Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01915459 on ClinicalTrials.gov