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Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

NCT00076687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2011-10-03

Study results available
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Summary

The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Conditions

  • Stroke
  • Muscle Spasticity
  • Motor Neuron Disease

Interventions

BIOLOGICAL

botulinum toxin Type A

botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18

BIOLOGICAL

botulinum toxin Type A

botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18

DRUG

saline

Saline injection at Day 1, Week 12, Week 18

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Czechia
  • Hungary
  • Poland

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 NCT00076687 on ClinicalTrials.gov