Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)

• Status: Terminated
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose for this study is to provide access to 3,4 DAP, a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and autonomic dysfunction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center; Jeffrey A. Cohen, MD
• Collaborator: Jacobus Pharmaceutical
• Treatments: 3,4-diaminopyridine; 4-Aminopyridine

Criteria

Inclusion Criteria: -Male or female majority between 45 and 60 years of age

• diagnosed with Lambert-Eaton Myasthenic Syndrome.

• subjects must be taking full dose of pyridostigmine

Exclusion Criteria: - does subject have a history of liver problems?

• does subject have a history of prolonged QTc syndrome (which is a condition where there is prolongation between the start of the Q wave and the end of the T wave in the heart's electrical cycle).