A Double-Blind, Placebo-Controlled, Crossover Study in Subjects with Cerebral Palsy to Evaluate the Safety and Tolerability and the Effect on Sensorimotor Function of Dalfampridine-ER

Principal Investigator: S. Ali Fatemi

The primary objective of the study is to determine the safety and tolerability of dalfampridine-ER 10 mg in subjects with cerebral palsy (CP). Exploratory objectives are to examine the effects of both single and multiple doses of dalfampridine-ER 10 mg on sensorimotor function as determined by the Box and Block test, pinch and grip tests, Timed 25 Foot Walk, and gait analysis.

This is a multi-center, double-blind, placebo-controlled, crossover study. The study will be divided into two parts, A and B, with different subjects enrolled into each part. In Part A, subjects will receive a single dose of investigational drug; in Part B, subjects will receive multiple doses of investigational drug. Part B will not begin until all the subjects from Part A have completed all visits and it has been confirmed that there is no safety signal that would preclude the administration of multiple doses.