This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Expanded access is currently available for this treatment.
Verified May 2017 by David Lacomis, University of Pittsburgh
Jacobus Pharmaceutical
Information provided by (Responsible Party):
David Lacomis, University of Pittsburgh Identifier:
First received: October 8, 2009
Last updated: May 4, 2017
Last verified: May 2017
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

Condition Intervention
Lambert-Eaton Myasthenic Syndrome Drug: 3,4 diaminopyridine

Study Type: Expanded Access     What is Expanded Access?
Official Title: Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Resource links provided by NLM:

Further study details as provided by David Lacomis, University of Pittsburgh:

Intervention Details:
    Drug: 3,4 diaminopyridine
    3,4 diaminopyridine up to 80 mg daily in divided doses
Detailed Description:

Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.

The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Diagnosis of LEMS
  2. Over 18 years old
  3. Medically stable
  4. If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study

Exclusion Criteria:

  1. Known sensitivity to 3,4 DAP
  2. History of past or current seizures
  3. History of severe asthma
  4. Believed by the investigator to be unable to comply with the protocol
  5. Unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00994916

Contact: David Lacomis, MD 412-647-1706

Sponsors and Collaborators
University of Pittsburgh
Jacobus Pharmaceutical
  More Information

Responsible Party: David Lacomis, Professor of Neurology and Pathology, University of Pittsburgh Identifier: NCT00994916     History of Changes
Other Study ID Numbers: IRB0410047
Study First Received: October 8, 2009
Last Updated: May 4, 2017

Keywords provided by David Lacomis, University of Pittsburgh:
Lambert-Eaton myasthenic syndrome
3,4 diaminopyridine

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Paraneoplastic Syndromes
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 processed this record on September 21, 2017