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2. Title: Open-label extension of double-blind, placebo-controlled, parallel group study to evaluate safety, tolerability and activity of oral Famipridine-SR in subjects with chronic incomplete spinal cord injury.(An extension study to evaluate the safety of oral fampridine-SR in persons with chronic spinal cord injury)

Purpose: The purpose of this study is to examine the continued effects of Fampridine-SR on bodily functions such as spasticity, bladder control, bowel function and sexual function in people who have participated in a study using either Fampridine-SR or placebo in the past. The study will also examine the possible long-term risks of taking Fampridine-SR. 

Principal Investigator: Ralph J. Marino, MD
Co-Investigator(s): Ramadevi Swaminath, MD; Bryan J. O'Neill, MD

Background: Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs.

In people with paralysis, some fibers might have been destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses.

As a result, patients with incomplete spinal cord injury may have trouble with control over their bowel and/or bladder function, may be unable to have satisfactory sexual relations, and may have muscle spasms or stiff muscles that make movement difficult.

Fampridine (4-aminopyridine, 4-AP), works by blocking "potassium channels."

Potassium channels are small openings that are found in the nerve processes in the spinal cord and brain, which help to control the size and speed of electrical impulses down the nerves.

It is believed that by blocking potassium channels, Fampridine increases the ability of the nerve to conduct electrical impulses. Fampridine has been reported to reduce spasticity and improve motor function in laboratory animals with spinal cord injury.

Initial studies in humans have shown that giving Fampridine by mouth or by vein to people with chronic, incomplete spinal cord injury may be associated with a range of benefits. Such benefits have included improvements in bladder and bowel control, sexual function, spasticity, motor and sensory function, and pain.

This study examines the continued effects of Fampridine-SR on bodily functions such as spasticity, bladder control, bowel function, and sexual function in people who have participated in a previous study using either Fampridine-SR or placebo in the past. The study investigates the possible long-term risks of taking Fampridine-SR.

Status: Completed

If you have participated in a previous Fampridine-SR study and would like to enroll in this trial, or for more information, please contact Mary Patrick, RN at 215-955-6579.