Inpatient Double-Blind Placebo-Controlled Withdrawal Study of 3,4-Diaminopyridine Base (3,4-DAP) in Subjects With Known Lambert-Eaton Myasthenic Syndrome
The objectives of the study are to confirm the safety and to test the efficacy of 3,4-DAP in
the treatment of LEMS-related weakness.
This is a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects
with known clinically active LEMS who have been on a chronic stable dose of compassionate
distribution Jacobus 3,4-DAP provided through FDA-approved individual investigator-held
INDs.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Triple Timed Up & Go (TUG) Test
Participants will be followed for up to 7 days
Yes
Kathy L Aleš, MD
Study Director
Jacobus Pharmaceutical
United States: Food and Drug Administration
JPC 3,4-DAPPER
NCT01511978
January 2012
August 2013
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Duke University | Durham, North Carolina 27710 |
University of Utah | Salt Lake City, Utah |
Oregon Health & Science University | Portland, Oregon 97201 |
Indiana University | Indianapolis, Indiana 46202 |
University of California at Davis | Sacramento, California 95817 |