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Dysport® Pediatric Lower Limb Spasticity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249417
First received: November 25, 2010
Last updated: December 8, 2016
Last verified: December 2016
November 25, 2010
December 8, 2016
July 2011
February 2014   (Final data collection date for primary outcome measure)
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).
Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ]
Complete list of historical versions of study NCT01249417 on ClinicalTrials.gov Archive Site
  • 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).
  • 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).
  • Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]
  • Measurement of progress towards individual therapy [ Time Frame: Week 4 ]
Not Provided
Not Provided
 
Dysport® Pediatric Lower Limb Spasticity Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cerebral Palsy
  • Muscle Spasticity
  • Children
  • Drug: Botulinum type A toxin (Dysport®)
    I.M. (in the muscle) injection on day 1 of a single treatment cycle.
  • Drug: Placebo
    I.M. injection on day 1 of a single treatment cycle.
  • 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.
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • 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.
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: Placebo
    Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
June 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   France,   Mexico,   Poland,   Turkey,   United States
 
 
NCT01249417
Y-55-52120-141
2009-017709-12 ( EudraCT Number )
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP