Cleveland, Ohio 44195


Purpose:

Compassionate use of orphan drug 3,4-Diaminopyridine (DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). The purpose of the use of this drug is to decrease the weakness associated with Lambert -Eaton Myasthenic Syndrome, and hopefully decrease the need for prednisone, and other therapies previously required to control your symptoms. The duration of the use of this drug will depend upon whether you see benefit from it, and whether any side effects from the drug prevent you from wishing to continue.


Criteria:

Inclusion Criteria: - Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission. None of these laboratory findings are required for inclusion in this study.• P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies. Exclusion Criteria: - Hypersensitivity to any component of this medication - History of past or current seizures - History of asthma - Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval. Many cardiologists consider an interval greater than 480-490 milliseconds to be abnormally prolonged. - Family history of prolonged QTc syndrome, history of unexplained syncope, seizures, or cardiac arrest. (The risk-benefit ratio should be carefully considered for those patients with a positive family history of a prolonged QTc, such as any unexpected sudden death, usually on exertion, in any relative under the age of 55, including unexplained automobile accidents, sudden infant death, amongst any family member down to fifth cousins). - Women who are pregnant, breast feeding or women of childbearing age who are not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception (unless sexually abstinent) for the duration of the trial.


NCT ID:

NCT00817856


Primary Contact:

Principal Investigator
Kerry H Levin, MD
The Cleveland Clinic


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States

Terese Wheeler
Phone: 216-444-9524
Email: wheelet@ccf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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