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NCT00056810 · ClinicalTrials.gov registry record · Phase 2
Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine
A Phase 2 study, sponsored by FDA Office of Orphan Products Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00056810 is a Phase 2 study that has completed, run by FDA Office of Orphan Products Development. The registered enrollment target is 30 participants.
The verdict
NCT00056810, a Phase 2 study, has completed, sponsored by FDA Office of Orphan Products Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG 4-aminopyridine (4-AP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-09 |
| Est. Completion | 2005-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00056810
The ClinicalTrials.gov registry entry for NCT00056810 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FDA Office of Orphan Products Development, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 4-aminopyridine (4-AP) is the first listed.
NCT00056810 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00056810 about?
NCT00056810 is a clinical study titled "Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine". 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 th...
What is the current status of trial NCT00056810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-09. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00056810?
The interventions under investigation include: 4-aminopyridine (4-AP) (DRUG).
Who is sponsoring clinical trial NCT00056810?
This trial is sponsored by FDA Office of Orphan Products Development, which has 10 total clinical trials registered on ClinicalTrials.gov.
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