Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-Aminopyridine
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Guillain-Barre Syndrome |
Drug: 4-aminopyridine (4-AP) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind |
| Official Title: | Assessment of Chronic GBS Improvement With Use of 4-AP |
- American Spinal Injury Association (ASIA) Motor Score at 8 weeks and 19 weeks
- Functional Independence Measure (FIM) Motor scale at 8 weeks and 19 weeks
- The following are all at 8 weeks and 19 weeks: Hand Dynamometer
- Visual Analog Pain Scale
- McGill Pain Questionnaire-Short Form
- Neuromuscular Functional Assessment Index
- Jebsen-Taylor Hand Function Test
- Minnesota Rate of Manipulation and Manual Dexterity Tests
- The Get Up and Go Test
- 6-Minute Walk Test
- Craig Handicap Assessment and Reporting Technique (CHART
- SF-12 Health Survey
- Center for Epidemiological Studies Depression Scale (CES-D)
- Positive and Negative Affect Schedule (PANAS)
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | May 2005 |
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.
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00056810 History of Changes |
| Other Study ID Numbers: | 2129 |
| Study First Received: | March 24, 2003 |
| Last Updated: | May 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by FDA Office of Orphan Products Development:
|
Guillain Barre Syndrome 4-aminopyridine |
Additional relevant MeSH terms:
|
Guillain-Barre Syndrome Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Polyneuropathies Autoimmune Diseases |
Immune System Diseases 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013