Study on 3,4-Diaminopyridine for Treating Lambert-Eaton Syndrome
Sponsor: University of Colorado, Denver
Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT01825395
This clinical trial is exploring how the medication 3,4-Diaminopyridine (3,4-DAP) affects patients with Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder.
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Program Overview
The purpose of this study is to understand the effects of the drug 3,4-Diaminopyridine (3,4-DAP) on individuals diagnosed with Lambert-Eaton myasthenic syndrome (LEMS). LEMS is a condition that affects the connection between nerves and muscles, leading to muscle weakness. This trial aims to see how well 3,4-DAP works in managing the symptoms of LEMS.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).
- If female, must have a negative pregnancy test.
- Premenopausal women must agree to use effective birth control during the study.
- Must not have a heart condition called prolonged QT syndrome, as shown by an ECG test.
- Must agree to have a second ECG test when the drug is most active in the body.
- Must understand the study and sign an informed consent form.
Exclusion Criteria
- Known allergy or sensitivity to 3,4-DAP.
- History of seizures, irregular heartbeats, liver, kidney, or blood diseases, or severe asthma.
- Believed by the study doctor to be unable to follow the study requirements.
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