Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects were eligible for participation in the study if they met the following criteria:
1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
2. 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.
3. 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 be if
Subjects were excluded from entering the study for the following reasons:
1. 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.
2. Unwillingness or inability to comply with the protocol.
3. 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.
4. 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.
5. Be pregnant and/or lactating.
6. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
7. An infection at the injection site(s).
8. Planned treatment with any new investigational drug or device during the study period.
Clareo Health | Dysport® Pediatric Lower Limb Spasticity Follow-on Study
