Imaging Results in Baclofen Efficacy and Safety Trials - A Multi-center Retrospective Chart Review of the Pediatric Population Using Oral Baclofen to Manage the Spasticity of Cerebral Palsy

Imaging Results data
Study Description
This was a multi-center retrospective chart review of pediatric subjects started on oral baclofen as treatment for spasticity of cerebral palsy (CP). Primary objectives included describing the characteristics of this population and the safety, effectiveness, and treatment course of oral baclofen. Subjects at seven sites with eligible charts were screened to identify 185 subjects who had started on oral baclofen. All 185 subjects had a full chart review and were included in the safety population; and all 185 subjects had documentation in their chart of both a baseline and post-baseline report of effectiveness (Movement/Tone Abnormality assessments), and were included in the efficacy population. Oral baclofen was used to manage spasticity of CP in pediatric subjects who mainly had 4 limb involvement, were on either none or one additional tone medication, and had low gross motor function and manual ability. As shown by the safety analysis, oral baclofen was safe and well tolerated in subjects with severe CP. A total of 185 subjects were identified who had been started on oral baclofen out of those with eligible charts.

影像结果数据
研究描述
本研究为一项多中心回顾性病历审查研究，纳入因脑瘫（cerebral palsy, CP）痉挛状态启动口服巴氯芬治疗的儿科受试者。本研究的主要目标为阐明该研究人群的特征，以及口服巴氯芬的安全性、有效性与治疗疗程。研究人员对7家研究中心中符合入组标准的受试者病历进行筛选，最终确定185名起始服用口服巴氯芬的受试者。所有185名受试者均完成完整病历审查，被纳入安全性分析人群（safety population）；同时所有受试者的病历中均留存有基线及基线后有效性评估报告（运动/肌张力异常评估，Movement/Tone Abnormality assessments）的相关记录，因此被纳入有效性分析人群（efficacy population）。本研究纳入的儿科受试者主要存在四肢受累情况，未联用或仅联用1种其他肌张力调节药物，且粗大运动功能与手功能均较差，均以口服巴氯芬改善脑瘫痉挛状态。安全性分析结果显示，口服巴氯芬在重度脑瘫受试者中安全性良好，耐受性佳。最终在符合入组标准的病历中，共筛选出185名起始服用口服巴氯芬的受试者。