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
2 other identifiers
interventional
241
6 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2011
Typical duration for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
November 29, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
February 3, 2017
CompletedSeptember 28, 2022
September 1, 2022
2.6 years
November 25, 2010
August 30, 2016
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
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).
Change from baseline to Week 4
Secondary Outcomes (2)
Physician's Global Assessment (PGA) of the Treatment Response.
Week 4
Goal Attainment Scale (GAS) Score
Week 4
Study Arms (3)
Dysport 10 U/Kg
EXPERIMENTAL10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Dysport 15 U/Kg
EXPERIMENTAL15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Placebo
PLACEBO COMPARATORTotal volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Interventions
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (29)
The Children's Hospital
Aurora, Colorado, 80045, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Children's Hospital of Michigan
Detroit, Michigan, 48202, United States
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, 55101, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Shriner's Hospital for Children
Portland, Oregon, 97210, United States
Texas Scottish Rite - Hospital for Children
Dallas, Texas, 75219, United States
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
Punta Arenas, Chile
Dr Roberto Del Rio Hospital
Santiago, Chile
Neurorehabilitation Laboratory, Pontifical Catholic University
Santiago, Chile
CHU Jean Minjoz
Besançon, France
Hospital San José Celaya
Celaya, Mexico
Centro de Rehabilitacion Infantil
Mexico City, Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Querétaro, Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, 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
Wiązowna, Poland
Ghulane Military Medical Academy and School of Medicine
Ankara, Turkey (Türkiye)
Ibn-i-Sina Hospital
Ankara, Turkey (Türkiye)
Yildirim Beyazit Training and Research Hospital
Ankara, Turkey (Türkiye)
GATA Haydarpasa Training Hospital
Istanbul, Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon
Istanbul, Turkey (Türkiye)
Istanbul University Medical School
Istanbul, Turkey (Türkiye)
Dokuz Eylül University Medical Faculty
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
İzmit, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2010
First Posted
November 29, 2010
Study Start
July 1, 2011
Primary Completion
February 1, 2014
Study Completion
June 1, 2014
Last Updated
September 28, 2022
Results First Posted
February 3, 2017
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.