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Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

NCT00234546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-07-26

No results posted yet for this study

Summary

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Conditions

  • Muscle Spasticity
  • Cerebrovascular Accident

Interventions

BIOLOGICAL

Botulinum toxin type A

1 injection, 500 U at day 0. The study will last for 6 months in each patient.

DRUG

Placebo

1 injection at day 0. The study will last for 6 months in each patient.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2007-10-31

Countries

  • Hong Kong
  • Malaysia
  • Philippines
  • Singapore
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00234546 on ClinicalTrials.gov