Dysport® Pediatric Lower Limb Spasticity Follow-on Study

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

Phase

3

Condition

Cerebral Palsy

Limb Spasticity

Treatment

N/A

Clinical Study ID

NCT01251380
Y-55-52120-147
2010-019102-17
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects were eligible for participation in the study if they met the following criteria:

  1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22or Week 28 follow up visit.
  2. Without any major protocol deviations and/or any ongoing adverse events (AEs), eitherof which, in the opinion of the Investigator would pose an unacceptable risk to thesubject were he/she to continue receiving treatment in this open label extensionstudy.
  3. Written informed consent obtained from the child's parent(s)/guardian(s) for thisstudy, and assent from the child when and where applicable.

Exclusion

Exclusion Criteria: Subjects were excluded from entering the study for the following reasons:

  1. Major limitation in the passive range of motion at the ankle, as defined by maximumankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle)in the most affected leg to be injected.
  2. Unwillingness or inability to comply with the protocol.
  3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC)and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
  4. Treatment with any drug that interferes either directly or indirectly withneuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents usedduring surgery (e.g. curare) within the last 30 days prior to study medication or aplanned treatment with such drugs.
  5. Be pregnant and/or lactating.
  6. Female subjects, not willing to use contraceptive measures throughout the course ofthe study if post pubertal and sexually active.
  7. An infection at the injection site(s).
  8. Planned treatment with any new investigational drug or device during the study period.

Study Design

Total Participants: 216
Study Start date:
October 01, 2011
Estimated Completion Date:
January 31, 2015

Connect with a study center

  • 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 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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