Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Detroit, Michigan 48201


Purpose:

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.


Study summary:

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: 58,029). 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.


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.


Study is Available At:


Original ID:

2129


NCT ID:

NCT00056810


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Assessment of Chronic GBS Improvement With Use of 4-AP


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

FDA Office of Orphan Products Development


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Study Dates

Start Date:September 2002
Completion Date:May 2005
Verification Date:May 2006
Last Changed Date:March 24, 2015
First Received Date:March 24, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:American Spinal Injury Association (ASIA) Motor Score at 8 weeks and 19 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Functional Independence Measure (FIM) Motor scale at 8 weeks and 19 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The following are all at 8 weeks and 19 weeks: Hand Dynamometer
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Visual Analog Pain Scale
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:McGill Pain Questionnaire-Short Form
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Neuromuscular Functional Assessment Index
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Jebsen-Taylor Hand Function Test
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Minnesota Rate of Manipulation and Manual Dexterity Tests
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The Get Up and Go Test
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-Minute Walk Test
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Craig Handicap Assessment and Reporting Technique (CHART
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:SF-12 Health Survey
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Center for Epidemiological Studies Depression Scale (CES-D)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Positive and Negative Affect Schedule (PANAS)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:4-aminopyridine (4-AP)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:FDA Office of Orphan Products Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.