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Completed Phase 3 Interventional Results available

Dysport® Adult Lower Limb Spasticity Study

ClinicalTrials.gov ID: NCT01249404

Public ClinicalTrials.gov record NCT01249404. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01249404
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ipsen
Industry
Enrollment
388 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2011 (Type not available)
Primary completion
Dec 2013 (Actual)
Completion
May 2014 (Actual)
Last update posted
Sep 28, 2022

2011 – 2014

United States locations

U.S. sites
17
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Mayo Clinic Arizona Scottsdale Arizona 85259 —
Rancho Los Amigos Downey California 90242 —
Pacific Neuroscience Medical Group Oxnard California 93030 —
Associated Neurologists of Southern CT, PC Fairfield Connecticut 06824 —
Parkinson's Disease & Movement Disorders Center of Boca Raton Boca Raton Florida 33486 —
Design Neuroscience Miami Gardens Florida 33169 —
Mount Sinai School of Medicine New York New York 10029 —
Weill Cornell Medical College New York New York 10065 —
University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599-7200 —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157 —
MossRehab & Albert Einstein Elkins Park Pennsylvania 19027 —
Vanderbilt University Nashville Tennessee 37232 —
The University of Texas Southwestern Medical Center at Dallas Dallas Texas 75390-9016 —
University of North Texas HSC at Ben Hogan Center Fort Worth Texas 76104 —
Neurorehabilitation Specialist Houston Texas 66211 —
University of Texas - Houston Houston Texas 77030 —
University of Utah School of Medicine Salt Lake City Utah 84132 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01249404, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2022 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01249404 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →