BPCA PEDIATRIC DRUG STUDY: BACLOFEN FOR CEREBRAL PALSEY

BPCA 儿科药物研究：巴氯芬治疗脑瘫

• 批准号: 8147299
• 金额: $ 54.99万
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8147299
• 关键词: Adolescent; Adverse event; Affect; Age; Baclofen; Best Pharmaceuticals for Children Act; Birth; Brain; Cerebral Palsy; Cerebrum; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Contracts; Data; Dose; Drug Kinetics; Drug Labeling; Drug usage; Effectiveness; Follow-Up Studies; Intervention; Label; Legal patent; Measures; Medical; Movement; Movement Disorders; National Institute of Child Health and Human Development; Oral; Oral Administration; Outcome; Patients; Performance; Pharmaceutical Preparations; Pharmacodynamics; Plasma; Population; Posture; Pregnancy; Prevention; Randomized Controlled Clinical Trials; Safety; Sample Size; United States National Institutes of Health; Withdrawal; dosage; early childhood; follow-up; injured; nervous system disorder; patient population; research study

The NICHD, as delegated by the NIH, is responsible for implementing the Congressionally-mandated Best Pharmaceuticals for Children Act of 2002, as reauthorized in 2007. The NICHD is responsible for the performance of clinical trials of priority, ¿off patent¿ drugs that are used in children but that lack sufficient pediatric labeling. One such drug is oral baclofen. The purpose of this contract is to conduct clinical research studies on pediatric use of oral baclofen that will provide data to FDA to support pediatric drug labeling of oral baclofen for spacticity of cerebral palsy. Cerebral palsy refers to a group of neurological disorders affecting control of movement and posture and which limit activity. The brain may be injured or develop abnormally during pregnancy, birth or in early childhood. The causes of cerebral palsy are not well understood. There is no known cure for CP. Medical intervention is limited to the treatment and prevention of complications arising from CP's effects. Oral baclofen is a drug that is sometimes used to treat the movement disorders arising from cerebral palsy. However, information regarding dosing, pharmokinetic parameters, effectiveness, and safety of this important drug in children and adolescents is incomplete. Up to four studies will be conducted under this contract to determine if oral baclofen is safe and effective in a pediatric population with cerebral palsy.

NICHD由NIH授权，负责实施国会授权的2002年儿童最佳药物法案，并于2007年重新授权。NICHD负责进行优先临床试验，即用于儿童但缺乏足够儿科标签的非专利药物。一种这样的药物是口服巴氯芬。本合同的目的是开展关于儿科使用口服巴氯芬的临床研究，为FDA提供数据，以支持口服巴氯芬治疗脑瘫空间性的儿科药物标签。 脑瘫是指一组影响运动和姿势控制并限制活动的神经系统疾病。在怀孕、分娩或幼儿期，大脑可能会受伤或发育异常。脑瘫的病因有哪些？没有已知的治疗CP的方法。医疗干预仅限于治疗和预防CP效应引起的并发症。小儿脑瘫的治疗方法有哪些？小儿脑瘫的治疗方法有哪些？然而，关于这种重要药物在儿童和青少年中的剂量、药代动力学参数、有效性和安全性的信息尚不完整。根据该合同，将进行多达四项研究，以确定口服巴氯芬在脑瘫儿童人群中是否安全有效。