Dysport® Pediatric Lower Limb Spasticity Study
- Conditions
- Muscle SpasticityChildrenCerebral Palsy
- Interventions
- Biological: Botulinum toxin type ADrug: Placebo
- Registration Number
- NCT01249417
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
- 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
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dysport 10 U/Kg Botulinum toxin type A 10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. Dysport 15 U/Kg Botulinum toxin type A 15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. Placebo Placebo Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
- Primary Outcome Measures
Name Time Method Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb 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
Name Time Method Goal Attainment Scale (GAS) Score 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. 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).
Trial Locations
- Locations (29)
Texas Scottish Rite - Hospital for Children
🇺🇸Dallas, Texas, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
🇲🇽Queretaro, Mexico
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
🇵🇱Gdansk, Poland
Hospital San José Celaya
🇲🇽Celaya, Mexico
Neurorehabilitation Laboratory, Pontifical Catholic University
🇨🇱Santiago, Chile
Hospital Central Dr Ignacio Morones Prieto
🇲🇽San Luis Potosi, Mexico
Dr Roberto Del Rio Hospital
🇨🇱Santiago, Chile
Centro de Rehabilitacion Infantil
🇲🇽Mexico City, Mexico
The Children's Hospital
🇺🇸Aurora, Colorado, United States
Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Gillette Children's Speciality Healthcare
🇺🇸Saint Paul, Minnesota, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital New Orleans
🇺🇸New Orleans, Louisiana, United States
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
🇨🇱Punta Arenas, Chile
Shriner's Hospital for Children
🇺🇸Portland, Oregon, United States
CHU Jean Minjoz
🇫🇷Besancon, France
B i L- Specjalistyczne Centrum Medyczne
🇵🇱Lodz, Poland
Non-public Healthcare Unit - Grunwaldzka Clinic
🇵🇱Poznan, Poland
Ghulane Military Medical Academy and School of Medicine
🇹🇷Ankara, Turkey
Non-public Healthcare Unit Mazovian Neurorehabilitatio
🇵🇱Wiazowna, Poland
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 University Medical School
🇹🇷Istanbul, Turkey
Dokuz Eylül University Medical Faculty
🇹🇷Izmir, Turkey
Istanbul Fizik Tedavi Rehabilitasyon
🇹🇷Istanbul, Turkey
Kocaeli University Medical Faculty
🇹🇷Izmit, Turkey