Acorda Therapeutics clinical trial on 4-aminopyridine (Fampridine) in chronic spinal cord injury

[Wise Young]

This trial has completed its enrollment of 90 patients ( http://www.acorda.com/ct.htm ) and is currently completing the followup assessments of the data. A phase 3 trial is being planned.

[This message was edited by Wise Young on July 30, 2001 at 11:08 AM.]

[Wise Young]

I had earlier responded to a question concerning this trial, indicating that Acorda is now analyzing the data from this phase 2 trial and planning a phase 3 pivotal trial to be submitted to the FDA. This should happen within the coming 3 months. Wise.
Cure Forum Posting on 4-AP (http://carecure.org/forum/showthread.php?t=13704)

[Wise Young]

http://www.rehabtrials.org/Trials/SKEV052K.shtml

Evaluating the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects with Chronic, Incomplete Spinal Cord Injury, and to Evaluate a New Patient Diary/Questionnaire
Principal Investigator: Steve Kirshblum, M.D.
Institution: Kessler Medical Rehabilitation Research & Education Corporation, West Orange NJ
Website: www.kmrrec.org (http://www.kmrrec.org)
Funding source:Acorda Therapeutics, Inc.
Status:
Last updated: 05/17/00

Objective: This is a late-stage Phase II clinical trial of patients with chronic incomplete (C4 - T10) spinal cord injury. Fampridine is a nerve conduction-enhancing compound in a sustained release oral tablet formulation which has been found to enhance bowel, bladder, and sexual function; to increase the ease of movement and sensation; and to reduce muscle spasticity. Ninety patients will be evaluated at ten rehabilitation centers.
Design: Double-blind, placebo-controlled, parallel group study
Setting: Clinical rehabilitation center.
Participants: Individuals with incomplete (C4 - T10) spinal cord injury.

[Wise Young]

Acorda is planning to carry out two phase 3 trials that will examine spasticity and sexual function in multiple centers. This will be announced when the FDA approves the protocols. Wise.

[Wise Young]

In addition to the two phase 3 trials, Acorda is planning a third trial which will include patients who have been in previous Acorda 4-AP trials, to provide the sustained release formulation on a long term basis to those patients.