Cerebral Palsy Clinical Trial
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
Verified date | September 2022 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 241 |
Est. completion date | June 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Chile | 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 | |
France | CHU Jean Minjoz | Besancon | |
Mexico | Hospital San José Celaya | Celaya | |
Mexico | Centro de Rehabilitacion Infantil | Mexico City | |
Mexico | Centro de Rehabilitacion Integral de Queretaro (CRIQ) | Queretaro | |
Mexico | Hospital Central Dr Ignacio Morones Prieto | San Luis Potosi | |
Poland | 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 | Wiazowna | |
Turkey | Ghulane Military Medical Academy and School of Medicine | Ankara | |
Turkey | Ibn-i-Sina Hospital | Ankara | |
Turkey | Yildirim Beyazit Training and Research Hospital | Ankara | |
Turkey | GATA Haydarpasa Training Hospital | Istanbul | |
Turkey | Istanbul Fizik Tedavi Rehabilitasyon | 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 | Kocaeli University Medical Faculty | Izmit | |
United States | The Children's Hospital | Aurora | Colorado |
United States | Rehabilitation Institute of Chicago | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Texas Scottish Rite - Hospital for Children | Dallas | Texas |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Shriner's Hospital for Children | Portland | Oregon |
United States | Gillette Children's Speciality Healthcare | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
United States, Chile, France, Mexico, Poland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Physician's Global Assessment (PGA) of the Treatment Response. | 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). | Week 4 | |
Secondary | Goal Attainment Scale (GAS) Score | 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). | Week 4 |
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