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

NCT00056810 | Completed Phase 2

• 1 other identifier: 2129
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Guillain-Barre Syndrome

Keywords

Guillain Barre Syndrome; 4-aminopyridine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• 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

Interventions

4-aminopyridine (4-AP) DRUG

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead

Study Sites (1)

Rehabilitation Institute of Michigan at Detroit Medical Center

Detroit, Michigan, 48201-2417, United States

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 24, 2003
• First Posted: March 25, 2003
• Study Start: September 1, 2002
• Study Completion: May 1, 2005
• Last Updated: March 25, 2015

Record last verified: 2006-05

Locations

US (1)