Clinical trial NCT01249417: Dysport® Pediatric Lower Limb Spasticity Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy
Muscle Spasticity
Children
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 241
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
timeFrame: Change from baseline to Week 4
Secondary outcomes:
measure: Physician's Global Assessment (PGA) of the Treatment Response.
timeFrame: Week 4
measure: Goal Attainment Scale (GAS) Score
timeFrame: Week 4
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Saint Paul
country: United States
facility: Gillette Children's Speciality Healthcare
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Shriner's Hospital for Children
state: Oregon
city: Dallas
country: United States
facility: Texas Scottish Rite - Hospital for Children
state: Texas
city: Punta Arenas
country: Chile
facility: Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
city: Santiago
country: Chile
facility: Dr Roberto Del Rio Hospital
city: Santiago
country: Chile
facility: Neurorehabilitation Laboratory, Pontifical Catholic University
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Celaya
country: Mexico
facility: Hospital San José Celaya
city: Mexico City
country: Mexico
facility: Centro de Rehabilitacion Infantil
city: Queretaro
country: Mexico
facility: Centro de Rehabilitacion Integral de Queretaro (CRIQ)
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr Ignacio Morones Prieto
city: Gdansk
country: Poland
facility: Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
city: Lodz
country: Poland
facility: B i L- Specjalistyczne Centrum Medyczne
city: Poznan
country: Poland
facility: Non-public Healthcare Unit - Grunwaldzka Clinic
city: Wiazowna
country: Poland
facility: Non-public Healthcare Unit Mazovian Neurorehabilitatio
city: Ankara
country: Turkey
facility: Ghulane Military Medical Academy and School of Medicine
city: Ankara
country: Turkey
facility: Ibn-i-Sina Hospital
city: Ankara
country: Turkey
facility: Yildirim Beyazit Training and Research Hospital
city: Istanbul
country: Turkey
facility: GATA Haydarpasa Training Hospital
city: Istanbul
country: Turkey
facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Fizik Tedavi Rehabilitasyon
city: Istanbul
country: Turkey
facility: Istanbul University Medical School
city: Izmir
country: Turkey
facility: Dokuz Eylül University Medical Faculty
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: