EUCTR2009-017723-26-IT进行中（未招募）不适用
A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injection in the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who have completed the double blind study (Study 140), up to the Week 12, Week 16, Week 20 or Week 24 follow up visit, and who do not have any major protocol deviation and/or any ongoing AEs (either of which, in the opinion of the Investigator, would pose an unacceptable risk to the subjects were they to continue receiving treatment) will be eligible for the study. Additionally, an informed consent for this open label extension study will be signed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 191
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 157
排除标准
- •Major limitation in the passive range of motion at the affected hip, knee or ankle, as defined by: ° maximum passive hip flexion (knee flexed) < 30º, ° maximum passive knee flexion (hip flexed) < 70º, ° maximum passive ankle dorsiflexion (knee flexed) < 10º, ° maximum passive knee extension < 160º. • Previous surgery on the affected muscles and ligaments, tendons or nerve trunks of the treated lower limb. • Previous treatment with phenol and/or alcohol in the treated lower limb at any time before the study. • Cognitive impairment altering the capacity to comply with the trial according to Investigator’s judgement. • Severe neurological impairment (not associated with the stroke or brain trauma) due to an underlying neuromuscular disease or any other underlying disease or condition affecting gait (for example, Multiple Sclerosis). • Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis). • Unwillingness or inability to comply with the protocol. • Major hypoaesthesia or ataxia on the paretic side. • Known sensitivity to Botulinum toxin (BTX) or any Dysport excipients. • Infection at the injection site(s). • Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (for example, aminoglycosides) within the last 4 weeks prior to study treatment. • Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study. • Treatment with a new investigational drug within 4 weeks prior to enrolment into the study or scheduled treatment with such a drug during the study period. • Any medical condition (or laboratory finding), that in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX.
研究者
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