Status:
COMPLETED
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
Lead Sponsor:
Ipsen
Conditions:
Cerebral Palsy
Muscle Spasticity
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 equin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01251380
Start Date
October 1 2011
End Date
January 1 2015
Last Update
September 28 2022
Active Locations (27)
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1
The Children's Hospital
Aurora, Colorado, United States, 80045
2
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
3
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48202