Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria

• Male or Female, 19 to 75 years of age, irrespective of race.

• Subject is able to and has voluntarily given informed consent prior to the performance of any study specific procedures.

• Subject has neurological impairment secondary to GBS, which has been stable for more than 12 months.

• Subject has motor strength that averages less than 5.0 but greater than 3.0 on the ASIA motor scale.

• Subject is able and willing to comply with protocol.

• Subjects will agree to no change in their outpatient therapy, or home exercise programs during enrollment in the study.