Dysport® Pediatric Lower Limb Spasticity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249417
Recruitment Status : Completed
First Posted : November 29, 2010
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Muscle Spasticity Children Drug: Botulinum type A toxin (Dysport®) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
Study Start Date : July 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dysport 10 U/Kg
10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Drug: Botulinum type A toxin (Dysport®)
I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Experimental: Dysport 15 U/Kg
15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Drug: Botulinum type A toxin (Dysport®)
I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Placebo Comparator: Placebo
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Drug: Placebo
I.M. injection on day 1 of a single treatment cycle.

Primary Outcome Measures :
  1. Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb [ Time Frame: Change from baseline to Week 4 ]
    The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

Secondary Outcome Measures :
  1. Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]
    PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the last injection?" Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).

  2. Goal Attainment Scale (GAS) Score [ Time Frame: Week 4 ]
    GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, as measured on the Modified Ashworth Scale

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01249417

  Hide Study Locations
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Louisiana
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, United States, 55101
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Shriner's Hospital for Children
Portland, Oregon, United States, 97210
United States, Texas
Texas Scottish Rite - Hospital for Children
Dallas, Texas, United States, 75219
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
Region de Magallanes y de la Antartica Chilena, Chile
Dr Roberto Del Rio Hospital
Santiago, Chile
Neurorehabilitation Laboratory, Pontifical Catholic University
Santiago, Chile
CHU Jean Minjoz
Besancon, France
Hospital San José Celaya
Celaya, Mexico
Centro de Rehabilitacion Infantil
Mexico City, Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Queretaro, Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi, Mexico
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
Gdansk, Poland
B i L- Specjalistyczne Centrum Medyczne
Lodz, Poland
Non-public Healthcare Unit - Grunwaldzka Clinic
Poznan, Poland
Non-public Healthcare Unit Mazovian Neurorehabilitatio
Wiazowna, Poland
Ghulane Military Medical Academy and School of Medicine
Ankara, Turkey
Ibn-i-Sina Hospital
Ankara, Turkey
Yildirim Beyazit Training and Research Hospital
Ankara, Turkey
GATA Haydarpasa Training Hospital
Istanbul, Turkey
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul, Turkey
Istanbul Fizik Tedavi Rehabilitasyon
Istanbul, Turkey
Istanbul University Medical School
Istanbul, Turkey
Dokuz Eylül University Medical Faculty
Izmir, Turkey
Kocaeli University Medical Faculty
Izmit, Turkey
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen

Responsible Party: Ipsen Identifier: NCT01249417     History of Changes
Other Study ID Numbers: Y-55-52120-141
2009-017709-12 ( EudraCT Number )
First Posted: November 29, 2010    Key Record Dates
Results First Posted: February 3, 2017
Last Update Posted: February 3, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents