TerminatedPhase 2

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

Stopped: Drug receive FDA approval

United States4 participantsStarted 2004-02

Plain-language 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.

Who can participate

Age range45 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Number of Participants That Showed Improvement in Muscle Weakness During Their Last Study Related Visit

Timeframe: Participants were followed until they withdrew or the study ended. Time frame ranged from 1 month to 3 years.

Trial details

NCT IDNCT02090725

SponsorJeffrey A. Cohen, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

Results submitted2019-03-26

View on ClinicalTrials.gov More Muscle Weakness trials