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

Study Status: Available
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Inpatient Double-Blind Placebo-Controlled Withdrawal Study of 3,4-Diaminopyridine Base (3,4-DAP) in Subjects With Known Lambert-Eaton Myasthenic Syndrome

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

Detailed Summary:

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.

Sponsor: Jacobus Pharmaceutical

Current Primary Outcome: Triple Timed Up & Go (TUG) Test [ Time Frame: Participants will be followed for up to 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Self-assessment of LEMS-related weakness [ Time Frame: Participants will be followed for up to 7 days ]

Original Secondary Outcome: Self-assessment of LEMS-related weakness [ Time Frame: Participants will be foillowed for up to 7 days ]

Information By: Jacobus Pharmaceutical

Dates:
Date Received: December 24, 2011
Date Started: January 2012
Date Completion: July 2014
Last Updated: July 1, 2014
Last Verified: July 2014