Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
Assessment of Chronic Guillain-Barre Syndrome Improvement with Use of 4-aminopyridine
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development |
---|---|
Information provided by: | FDA Office of Orphan Products Development |
Purpose
In developed countries, Guillain-Barre Syndrome (GBS) is the most common cause of acute neuromuscular paralysis, afflicting about 5,000 persons annually in the United States. Over 20% of GBS patients have permanent residual motor deficits that affect their activities of daily living. The goal of this study is to assess the potential usefulness and safety of 4-aminopyridine (4-AP) in those patients who suffer chronic functional deficits from GBS.This medication is a potassium channel blocker that has the potential to improve nerve conduction, particularly across partially demyelinated axons. It is felt that by increasing nerve conduction there will be improved motor performance for walking and activities of daily living, as well as decreased fatiguability. This medication has demonstrated potential usefulness in central demyelinating diseases such as multiple sclerosis.Because the peripheral nervous system is much more accessible to systemic medication delivery it is felt that this medication may improve the functional status of those patients who are suffering from the residual side effects of this medication.
Condition | Treatment or Intervention | Phase |
---|---|---|
Guillain-Barre Syndrome |
Drug: 4-aminopyridine (4-AP) |
Phase II |
MedlinePlus related topics: Guillain-Barre Syndrome
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Assessment of Chronic GBS Improvement with Use of 4-AP
Expected Total Enrollment: 30
Study start: September 2002;
Study completion: September 2004
Objective.- To determine the safety and efficacy of orally delivered 4-aminopyridine for motor weakness due to Guillain-Barre Syndrome (GBS) under a FDA approved protocol (IND No: 58,029). Setting.- Tertiary care outpatient rehabilitation center directly attached to a university hospital. Subjects.- Subjects who are unable to ambulate more than 200 feet without assistive devices and have residual nonprogressive motor weakness due to GBS more than one year out from the initial episode. Design.- Subjects will be randomized to a double-blind, placebo-controlled, cross-over design, which had two eight-week treatment arms with a three-week washout. The average dosage at 4 weeks will be 30 milligrams (mg) per day. Patients who demonstrate improvement will be continued on the medication for an additional three months. Assessments will be performed every two weeks during the randomized trial and every month for those continued for up to three months on the medication.
Eligibility
Ages Eligible for Study: 19 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |