2024-518447-38-00招募中2 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. PROTOCOL CODE: INCIPIT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)
研究概览
简要总结
to investigate the efficacy of IncobotulinumtoxinA in the treatment of both BoNT-A naïve and pretreated children for upper and lower limb spasticity using a dose titration approach over three injection cycles, with a flexible observation period after injection of 12 to 20 weeks and a total duration of exposure up to 60 weeks
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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
- •Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern
- •Patient 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 or legal guardian
排除标准
- •Participation in other trials
- •BoNT-A treatment contraindicated
- •Therapy with anticoagulants or other substances that could have an anticoagulant effect
- •Girls of childbearing potential (defined as females post menarche)
- •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
结局指标
主要结局
Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)
Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)
次要结局
- Efficacy endpoint: Scala di Ashworth
- REsistance to PAssive movement Scale (REPAS)
- The GMFCS
- The visual analog scale (VAS)
- The Goal Attainment scale (GAS)
- The Global Assessment of Efficacy
- Safety endpoints: Values of blood pressure, heart rate, and respiratory rate
- Values of Body Weight
- adverse events
- The Global Assessment of Tolerability
研究者
Nicola Smania
Scientific
Azienda Ospedaliera Universitaria Integrata Verona
研究点 (1)
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