drugset / Trial / NCT00056810

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

NCT00056810

Phase 2 Completed 30 enrolled FDA Office of Orphan Products Development
RandomizedCrossoverDouble-blind

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.

Timeline

Start
2002-09
Primary completion
Completion
2005-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalfampridine Small molecule 30 mg Oral