A PHASE III, PROSPECTIVE, MULTICENTRE, OPEN LABEL, EXTENSION STUDY ASSESSING THE LONG TERM SAFETY AND EFFICACY OF REPEATED TREATMENT WITH DYSPORT USED IN THE TREATMENT OF LOWER LIMB SPASTICITY IN CHILDREN WITH DYNAMIC EQUINUS FOOT DEFORMITY DUE TO CEREBRAL PALSY

Ipsen Pharma SAS0 个研究点目标入组 221 人开始时间: 2012年1月31日最近更新: 2015年2月16日

试验速览

暂无简介。

•All subjects must fulfil the following inclusion criteria to be eligible for the study:
•(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 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 221
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects are to be excluded if any of the following apply:
•(1) Major limitation in the passive range of motion at the ankle, as
•defined by maximum ankle dorsiflexion measured by Tardieu
•Scale XV1 of <80° (Tardieu 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
•(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) (6)Female subjects who are 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.

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