Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Completed · Phase 1 · Has a placebo group

Conditions studied: Cerebral Palsy (CP)

In brief

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

Key facts

Study ID

NCT01468350

Run by

Acorda Therapeutics

People needed

35

Starts

2011-12-01

Expected to finish

2013-03-01

Last updated by the study team

2014-06-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Rancho Los Amigos National Rehabilitation Center — Downey, California, United States
• UCLA/Orthopaedic Hospital Center for Cerebral Palsy — Los Angeles, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Kennedy Krieger Institute at Johns Hopkins University — Baltimore, Maryland, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
• University of Missouri at Columbia — Columbia, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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