EUCTR2019-003559-12-IT进行中（未招募）1 期
Prospective, open-label, non-randomized, single-arm, dose titration study to investigate the efficacy and safety of IncobotulinumtoxinA in children deemed to require a total body dose up to 22U/kg (maximum dose 550U) during the study period for the treatment of upper and lower limb spasticity due to cerebral palsy - IncobotulinumtoxinA in ChIldren with upper and lower limb spasticity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Children (female or male) aged 2 to 17 years
- •Patients with upper and lower limb spasticity due to cerebral palsy
- •Gross Motor Function Classification System (GMFCS) from Level II to Level V
- •Selected target clinical pattern diagnosed by a qualified health care professional (i.e. physiatrist)
- •Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern [12]
- •Patients deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period
- •In the case of children pretreated with BoNT-A, time from last injection at least 5 months
- •Informed consent signed by parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •Participation in other trials
- •BoNT-A treatment contraindicated
- •Presence of fixed contractures, or bony deformities of the affected limbs
- •Previous treatment of spastic muscles with nerve phenolization
- •Other neurological or orthopedic conditions involving the affected limbs
- •institutionalized patients
- •girls with childbearing potential (defined as females post menarche)
研究者
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