Dysport® Pediatric Lower Limb Spasticity Follow-on Study
Completed · Phase 3
Conditions studied: Cerebral Palsy, Muscle Spasticity, Children
In brief
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
Key facts
- Study ID
- NCT01251380
- Run by
- Ipsen
- People needed
- 216
- Starts
- 2011-10-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2022-09-28
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects were eligible for participation in the study if they met the following criteria:
- Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
- Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
- Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.
You may not qualify if…
- Subjects were excluded from entering the study for the following reasons:
- Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle) in the most affected leg to be injected.
- Unwillingness or inability to comply with the protocol.
- Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
- Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.
- Be pregnant and/or lactating.
- Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
- An infection at the injection site(s).
- Planned treatment with any new investigational drug or device during the study period.
Where it is running
- The Children's Hospital — Aurora, Colorado, United States
- Rehabilitation Institute of Chicago — Chicago, Illinois, United States
- Children's Hospital New Orleans — New Orleans, Louisiana, United States
- Children's Hospital of Michigan — Detroit, Michigan, United States
- Gillette Children's Speciality Healthcare — Saint Paul, Minnesota, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Shriner's Hospital for Children — Portland, Oregon, United States
- Texas Scottish Rite - Hospital for Children — Dallas, Texas, 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
- 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 University Medical School — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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