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Dysport® Adult Lower Limb Spasticity Study

NCT01249404 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2022-09-28

Study results available
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Summary

The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

Conditions

  • Leg Spasticity

Interventions

BIOLOGICAL

Botulinum toxin type A

I.M. injection on day 1 (single treatment cycle)

DRUG

Placebo

I.M. injection on day 1 (single treatment cycle)

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2014-05-31

Countries

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

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 NCT01249404 on ClinicalTrials.gov