Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome

In brief

Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.

Key facts

Study ID

NCT01511978

Run by

Jacobus Pharmaceutical

People needed

32

Starts

2012-01-01

Expected to finish

2015-07-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or over
• Ambulatory while taking 3,4-DAP, i.e. the patient was able to perform the timed up and go (TUG), either with or without an assistive device
• Established diagnosis of LEMS, with documentation provided
• Continuous use of Jacobus 3,4-DAP for at least 3 months
• Minimum of 3 doses per day with no single dose less than 10 mg of 3,4-DAP
• The patient needed to wait about 15 to 30 minutes to experience an unequivocal improvement in a LEMS-induced dysfunction after they take their first dose of 3,4-DAP in the morning [a patient who remains in bed past this point by choice may still be eligible]
• Stable regimen of all LEMS-related treatments for at least 3 months
• Stable daily regimen of other medications (prescription and over-the-counter) for a minimum of 1 month
• Willing to chance being tapered off of 3,4-DAP
• Fluency in English
• If applicable, agreed to use birth control during heterosexual intercourse until at least 2 weeks after completion of study
• A signed informed consent by the study subject

You may not qualify if…

• Last monoclonal antibody treatment (e.g. rituximab) was less than 6 months ago (i.e., recent treatment is an exclusion)
• Clinically significant or poorly controlled condition that in the opinion of the study personnel might pose an unacceptable risk to the patient if entered into the study
• Respiratory failure requiring intubation while on 3,4-DAP with no precipitating event or medication
• Use of any investigational drug other than 3,4-DAP within the last 30 days
• Pregnant or lactating
• Current use of other aminopyridines (e.g.4-AP) or guanidine
• Did not display a sufficiently large response to 3,4-DAP during the baseline observation period in the CRU to detect a decline during withdrawal of 3,4-DAP

Where it is running

• University of California at Davis — Sacramento, California, United States
• Indiana University — Indianapolis, Indiana, United States
• Duke University — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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