Dysport® Adult Upper Limb Spasticity Extension Study

Last updated: September 15, 2022
Sponsor: Ipsen
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT01313312
Y-52-52120-148
2010-019162-83
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of the double blind study, Y-52-52120-145

Exclusion

Exclusion Criteria:

  • Major limitation in the passive range of motion in upper limb

Study Design

Total Participants: 258
Study Start date:
November 01, 2011
Estimated Completion Date:
December 31, 2014

Study Description

This was a phase III, multicentre, prospective, open label, repeat treatment cycles, extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover subjects from Study 145 and de novo subjects. The primary study objective was to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. The secondary study objective was to assess the long term efficacy of repeated treatment with Dysport®.

Connect with a study center

  • Université catholique de Louvain av Hippocrate 10

    Bruxelles,
    Belgium

    Site Not Available

  • Clinique Universitaire

    Yvoir,
    Belgium

    Site Not Available

  • Neurologicka klinika

    Olomouc,
    Czech Republic

    Site Not Available

  • Charles University in Prague

    Praha 2,
    Czechia

    Site Not Available

  • CHU Jean MINJOZ

    Besançon,
    France

    Site Not Available

  • CHU Jean MINJOZ

    Besançon,
    France

    Site Not Available

  • CHU Brest

    Brest,
    France

    Site Not Available

  • Centre de Réadaptation de Coubert

    Coubert,
    France

    Site Not Available

  • Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

    Créteil,
    France

    Site Not Available

  • Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

    Créteil,
    France

    Site Not Available

  • Hopital Raymond Poincarré

    Garches,
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • Hôpital Sébastopol

    Reims,
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Hopital Rangueil

    Toulouse,
    France

    Site Not Available

  • Petz Aladar County Hospital

    Gyor, Budapest
    Hungary

    Site Not Available

  • National Institute for Medical Rehabilitation

    Budapest,
    Hungary

    Site Not Available

  • Azienda Hospedaliero

    Catania,
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Site Not Available

  • Malopolskie Centrum Medyczne

    Krakow,
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii

    Warszawa,
    Poland

    Site Not Available

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warszawa,
    Poland

    Site Not Available

  • Medical Rehabilitation Center

    Moscow,
    Russian Federation

    Site Not Available

  • Scientific Center of Neurology of RAMS

    Moscow,
    Russian Federation

    Site Not Available

  • State University

    St Petersburg,
    Russian Federation

    Site Not Available

  • Derer's Hospital

    Bratislava,
    Slovakia

    Site Not Available

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Site Not Available

  • Associated Neurologist of Southern CT, PT

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Parkinson's Disease & Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33488
    United States

    Site Not Available

  • Design Neuroscience Miami

    South Miami, Florida 33143
    United States

    Site Not Available

  • The Rehabilitation Institute of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • International Clinical Research Institute

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029-6574
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Univ of North Carolina - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Wake Forest Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Southwestern Medical Center at Dallas University of Texas

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of North Texas HSC at Ben Hogan Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • University of Utah School of Medicine

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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