MedTrace Logo

BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

NCT01575054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2016-09-28

Study results available
· View outcomes & findings →

Summary

This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

Conditions

  • Muscle Spasticity

Interventions

BIOLOGICAL

botulinum toxin Type A

Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.

DRUG

Normal Saline

Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.

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
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-09-30
Completion
2015-07-31

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Russia
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

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 NCT01575054 on ClinicalTrials.gov