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Dysport® Pediatric Lower Limb Spasticity Study

This study is currently recruiting participants.
Verified April 2013 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249417
First received: November 25, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes

November 25, 2010
April 22, 2013
July 2011
July 2014   (final data collection date for primary outcome measure)
Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
  • Measurement of progress towards individual therapy [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
228
December 2014
July 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 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
Both
2 Years to 17 Years
No
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
United States,   Chile,   France,   Mexico,   Poland,   Turkey
 
NCT01249417
Y-55-52120-141
No
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
April 2013

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