PEDIATRIC PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF

儿科药代动力学和药效学研究

• 批准号: 8166714
• 负责人: ALOYSIA SCHWABE
• 金额: $ 0.11万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166714
• 关键词: Age; Baclofen; Caring; Child; Childhood; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Dystonia; Enrollment; Funding; Grant; Institution; Measures; Muscle; Oral; Oral Administration; Pain; Pharmacodynamics; Plasma; Randomized; Research; Research Personnel; Resources; Safety; Site; Source; Titrations; United States National Institutes of Health; age group; experience; health related quality of life; improved; open label

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label, multiple-dose, ascending dose study in approximately 85 subjects in 3 age groups (ages greater than 2 to less than 6 years, 6 to less than 12 years and 12 to 16 years), to be conducted at approximately nine investigative sites with access to general clinical research centers (GCRCs) with pediatric experience. Each of these sites will enroll approximately 12 subjects (total of approximately 108 subjects) to allow for discontinuation of subjects prior to study completion and titration of a sufficient number of subjects to each dose level. Baclofen will decrease in the activity of the muscles that are over active making it easier for the subject to move and better interact with his/her surroundings and other people Primary objectives: 1. Determine pharmacokinetic parameters of oral baclofen in children with spasticity associated with CP. 2. Describe the relationship between plasma concentrations of oral baclofen and clinical measures of spasticity. 3. Determine optimal dosing range and interval for administration of oral baclofen for use in a randomized clinical study of safety and efficacy. Secondary objectives: 1. Describe the relationship between plasma concentrations of oral baclofen and measures of strength, function, ease of care, pain/comfort and health related quality of life. 2. Describe the safety and tolerability of oral baclofen in children with spasticity associated with CP. 3. Investigate preliminarily whether oral baclofen improves dystonia.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项开放标签、多次给药、剂量递增研究，在3个年龄组（年龄大于2岁至小于6岁、6岁至小于12岁和12岁至16岁）约85例受试者中进行，将在约9家可访问具有儿科经验的一般临床研究中心（GCRC）的研究中心进行。每个研究中心将入组约12例受试者（总计约108例受试者），以允许在研究完成前中止受试者并滴定足够数量的受试者 每个剂量水平的受试者数量。 巴氯芬将减少过度活跃的肌肉的活动，使受试者更容易移动，并更好地与他/她的周围环境和其他人互动 主要目标：1。确定口服巴氯芬在脑瘫痉挛儿童中的药代动力学参数。2.描述口服巴氯芬的血浆浓度与痉挛临床指标之间的关系。3.确定口服巴氯芬的最佳剂量范围和给药间隔，用于安全性和有效性的随机临床研究。 次要目标：1。描述口服巴氯芬的血浆浓度与强度、功能、护理便利性、疼痛/舒适度和健康相关生活质量指标之间的关系。2.描述口服巴氯芬治疗脑瘫相关痉挛儿童的安全性和耐受性。3.初步探讨口服巴氯芬能否改善肌张力障碍。