A Phase IV, Prospective, Open Label, Multi-Centre, Single arm, Post market surveillance study to confirm the safety and efficacy of Intramuscular Injection of Xeomin (Clostridium Botulinum neurotoxin type A) in the Management of Lower Limb Spasticity in the Indian Pediatric and Adolescent population.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Incidence rates of adverse events (AEs) and serious adverse events (SAEs),
研究概览
简要总结
This study aims to evaluate the safety and efficacy of Clostridium Botulinum neurotoxin type A, Xeomin, for the management of lower limb spasticity in the Indian pediatric and adolescent population. The primary objective is to assess safety by monitoring the incidence of adverse events, serious adverse events, and treatment-emergent adverse events from baseline to follow-up. The secondary objective is to evaluate efficacy through changes in modified Ashworth Scale scores, Global Impression of Change Scores by investigators, patients, and caregivers, spasticity-related pain using a questionnaire, and improvement in motor function using the Gross Motor Function Measure-66. These parameters will be assessed at baseline, Week 4, Week 8, and Week 12.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 2 to 17 years with spasticity due to neurological disorders.
- •Minimum weight of 10 kg at the screening and day 1 visits.
- •Ankle spasticity equal to or greater than 2 in affected lower limb, as measured on the Modified.
- •Ashworth Scale and GMFM-
- •Equinovarus or equinovalgus deformities are acceptable.
- •No infection or inflammation in the planned injection sites.
- •Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- •Subject willing and able to comply with the study protocol.
排除标准
- •Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease.
- •Uncontrolled epilepsy as more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit or history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc) more than once a month, seizures lasting more than 10 minutes, status epilepticus, or epilepsy with autonomic involvement.
- •Botulinum Toxin therapy of any serotype for any condition within the last 6 months prior to the day 1 visit.
- •History of surgical intervention of the lower study leg or planned surgery of any limb during the study
- •Previous casting within 6 months prior to the day 1 visit or with a dynamic splint (eg, Dynasplint®) within 3 months prior to the day 1 visit for spasticity of the study limb or affected limb during the study.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
结局指标
主要结局
Incidence rates of adverse events (AEs) and serious adverse events (SAEs),
时间窗: Time Frame: week 1, week 4, week 8, week 12
Treatment – emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Time Frame: week 1, week 4, week 8, week 12
次要结局
- 1. Change from baseline in the modified- AS score of affected muscle groups(2. GICS Investigator’s, patient and parent’s/caregiver’s will be recorded)
研究者
Dr Vishal Vishnoi
Subharti Medical College And Hospital