Original Query: Paraneoplastic Syndromes
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Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome (3 4-DAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01825395
Recruitment Status : Available
First Posted : April 5, 2013
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

Condition or disease Intervention/treatment
Lambert Eaton Myasthenic Syndrome Drug: 3, 4-Diaminopyridine

Study Type : Expanded Access
Official Title: Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
Study Start Date : July 2004
Estimated Primary Completion Date : February 2050
Estimated Study Completion Date : March 2050

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older,
  • Diagnosed with LEMS,
  • If female, have a negative pregnancy test, and
  • If premenopausal, be willing to practice an effective form of birth control during the study,
  • Tested and found by ECG not to have a prolonged QT syndrome,
  • Agree to have a second ECG at the time of peak drug effect,
  • Has understood and signed the Informed Consent.

Exclusion Criteria:

  • Is known to have a sensitivity to 3, 4-DAP,
  • Has a history of:

    1. past or current seizures,
    2. cardiac arrhythmia,
    3. hepatic, renal or hematologic disease, or
    4. severe asthma,
  • Is believed by the investigator to be unable to comply with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01825395

Contact: Kathy Ales 609-921-7447

United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Contact: Janet Jones    303-724-2188      
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Steven P Ringel, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT01825395     History of Changes
Other Study ID Numbers: 04-0567
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Pathologic Processes
Nervous System Neoplasms
Neoplasms by Site
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action