Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• A diagnosis of CP

• No previous use of any dalfampridine formulation

• Ability to perform all the required study procedures. Subjects should be capable of fully extending and flexing both hands

Exclusion Criteria:

• Presence of any progressive neurological disease

• Severe CP defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. This definition includes spastic quadriplegia

• Pregnant or breastfeeding