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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: Completed Phase 2 study, sponsored by FDA Office of Orphan Products Development.
NCT00056810 is a Phase 2 study that has completed, run by FDA Office of Orphan Products Development. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00056810 record still lists
NCT00056810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which 4-aminopyridine (4-AP) is the first listed.
NCT00056810 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00056810's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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