Baseline Events/Symptoms 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

Baseline Events/Symptoms 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.