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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00056810 |
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 | Intervention | Phase |
---|---|---|
Guillain-Barre Syndrome |
Drug: 4-aminopyridine (4-AP) |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Chronic GBS Improvement With Use of 4-AP |
Estimated Enrollment: | 30 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | May 2005 |
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.
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Study ID Numbers: | 2129 |
Study First Received: | March 24, 2003 |
Last Updated: | May 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00056810 |
Health Authority: | United States: Food and Drug Administration |
Guillain Barre Syndrome 4-aminopyridine |
Autoimmune Diseases Acute idiopathic polyneuritis Guillain-Barre syndrome Neuromuscular Diseases Demyelinating Diseases Polyradiculoneuropathy |
Guillain-Barre Syndrome Peripheral Nervous System Diseases Polyneuropathies 4-Aminopyridine Demyelinating diseases Autoimmune Diseases of the Nervous System |
Membrane Transport Modulators Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses |
Syndrome Nervous System Diseases Potassium Channel Blockers Cardiovascular Agents Pharmacologic Actions |