Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056810
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2003-03-24
Brief Title:
Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Assessment of Chronic GBS Improvement With Use of 4-AP
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In developed countries Guillain-Barre Syndrome GBS is the most common cause of acute neuromuscular paralysis afflicting about 5000 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 GBSThis 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 sclerosisBecause 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
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 GBSThis 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 sclerosisBecause 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
Detailed Description:
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 58029
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None