Dysport® Pediatric Lower Limb Spasticity Follow-on Study
United States216 participantsStarted 2011-10
Plain-language summary
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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.
Timeframe: From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.