Dysport® Pediatric Lower Limb Spasticity Study

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

Phase

3

Condition

Limb Spasticity

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT01249417
Y-55-52120-141
2009-017709-12
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 2 to 17 years with cerebral palsy
  • Equinus foot position
  • Ambulatory
  • Intensity of muscle tone equal to or greater than 2 in affected lower limb, asmeasured on the Modified Ashworth Scale

Exclusion

Exclusion Criteria:

  • Fixed contracture
  • Previous phenol, alcohol injection or surgical intervention
  • Other neurological / neuromuscular disorder
  • Severe athetoid or dystonic movements

Study Design

Total Participants: 241
Study Start date:
July 01, 2011
Estimated Completion Date:
June 30, 2014

Connect with a study center

  • Neurorehabilitation Laboratory, Pontifical Catholic University

    Chile,
    Chile

    Site Not Available

  • Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas

    Punta Arenas,
    Chile

    Site Not Available

  • Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas

    Region de Magallanes y de la Antartica Chilena,
    Chile

    Site Not Available

  • Dr Roberto Del Rio Hospital

    Santiago,
    Chile

    Site Not Available

  • Neurorehabilitation Laboratory, Pontifical Catholic University

    Santiago,
    Chile

    Site Not Available

  • CHU Jean Minjoz

    Besancon,
    France

    Site Not Available

  • Centre des Massues - Hopital de Jour

    Lyon,
    France

    Site Not Available

  • Hopital National de Saint-Maurice

    St Maurice,
    France

    Site Not Available

  • CHU Rangueil

    Toulouse,
    France

    Site Not Available

  • Hospital San José Celaya

    Celaya,
    Mexico

    Site Not Available

  • Centro de Rehabilitacion Infantil

    Mexico City,
    Mexico

    Site Not Available

  • Centro de Rehabilitacion Integral de Queretaro (CRIQ)

    Queretaro,
    Mexico

    Site Not Available

  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosi,
    Mexico

    Site Not Available

  • Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU

    Gdansk,
    Poland

    Site Not Available

  • B i L- Specjalistyczne Centrum Medyczne

    Lodz,
    Poland

    Site Not Available

  • Prof. Antoni Gebala Children Hospital

    Lublin,
    Poland

    Site Not Available

  • Non-public Healthcare Unit - Grunwaldzka Clinic

    Poznan,
    Poland

    Site Not Available

  • Non-public Healthcare Unit Mazovian Neurorehabilitatio

    Wiazowna,
    Poland

    Site Not Available

  • Ghulane Military Medical Academy and School of Medicine

    Ankara,
    Turkey

    Site Not Available

  • Ibn-i-Sina Hospital

    Ankara,
    Turkey

    Site Not Available

  • Yildirim Beyazit Training and Research Hospital

    Ankara,
    Turkey

    Site Not Available

  • GATA Haydarpasa Training Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul Fizik Tedavi Rehabilitasyon

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul University Medical School

    Istanbul,
    Turkey

    Site Not Available

  • Dokuz Eylül University Medical Faculty

    Izmir,
    Turkey

    Site Not Available

  • Kocaeli University Medical Faculty

    Izmit,
    Turkey

    Site Not Available

  • The Children's Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Associated Neurologist of Southern CT, PC

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Child Neurology Associates, P.C

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Rehabilitation Institute of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Children's Hospital New Orleans

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Gillette Children's Speciality Healthcare

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Shriner's Hospital for Children

    Portland, Oregon 97210
    United States

    Site Not Available

  • Texas Scottish Rite - Hospital for Children

    Dallas, Texas 75219
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Primary Children's Medical Center

    Salt Lake City, Utah 84113
    United States

    Site Not Available

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