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Dysport® Adult Lower Limb Spasticity Follow-on Study

NCT01251367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2022-09-28

Study results available
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Summary

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Conditions

  • Post-stroke Spasticity
  • Spasticity Post-Traumatic Brain Injury

Interventions

BIOLOGICAL

Botulinum toxin type A

I.M. (intramuscular) injection on day 1 of each treatment cycle.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

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 NCT01251367 on ClinicalTrials.gov