Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 12
- 主要终点
- Preventive Pain Management Technique
研究概览
简要总结
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.
OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.
Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
- •Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
- •Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached.
- •Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
- •Participants with physio/physical therapy can be included.
排除标准
- •Previously treated with botulinum toxin for spasticity related to cerebral palsy.
- •Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
- •History of hypersensitivity to the study drug or to any of the excipients in the formulation.
- •Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
- •Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
- •Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.
研究组 & 干预措施
OnabotulinumtoxinA
Participants will receive OnabotulinumtoxinA as prescribed by their physician.
结局指标
主要结局
Preventive Pain Management Technique
时间窗: Up to 12 months
Type of method used to control procedural pain will be assessed.
Re-administration Interval
时间窗: Up to 12 months
Re-administration interval is defined as number of days between drug application and previous application.
Total Dose Per Kilogram
时间窗: Up to 12 months
OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.
Dose Per Muscle
时间窗: Up to 12 months
OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.
Method to Locate Application Site
时间窗: Up to 12 months
Type of method used to identify muscle and treatment application site will be assessed.
Absolute Total Dose
时间窗: Up to 12 months
OnabotulinumtoxinA total dose applied at visit will be assessed.
Needle Gauge
时间窗: Up to 12 months
Needle gauge is defined as diameter of needle thickness with which study treatment is applied.
Application Sites Number Per Muscle
时间窗: Up to 12 months
Number of puncture sites per muscle will be assessed.
Needle Length
时间窗: Up to 12 months
Needle length is defined as distance from the needle base to the needle bevel tip.
次要结局
未报告次要终点