Intrathecal baclofen for management of spastic cerebral palsy: Multicentertrial

Intrathecal baclofen infusion has demonstrated effectiveness in decreasing spasticity of spinal origin. Oral antispasticity medication is minimally ef fective or not well tolerated in cerebral palsy. This study assessed the ef fectiveness of intrathecal baclofen in reducing spasticity in cerebral pals y. Candidates were screened by randomized, double-blind, intrathecal inject ions of baclofen and placebo. Responders were defined as those who experien ced an average reduction of 1.0 in the lower extremities on the Ashworth Sc ale for spasticity. Responders received intrathecal baclofen via the Synchr oMed System and were followed for up to 43 months. Fifty-one patients compl eted screening and 44 entered open-label trials, Lower-extremity spasticity decreased from an average baseline score of 3.64 to 1.90 at 39 months. A d ecrease in upper-extremity spasticity was evidenced over the same study per iod. Forty-two patients reported adverse events. Most common reports were h ypotonia, seizures (no new onset), somnolence, and nausea or vomiting. Fift y-nine percent of the patients experienced procedural or system-related eve nts. Spasticity in patients with cerebral palsy can be treated effectively by continuous intrathecal baclofen, Adverse events, although common, were m anageable.