Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Expanded access is currently available for this treatment.
Verified December 2015 by University of Pittsburgh
Jacobus Pharmaceutical
Information provided by (Responsible Party):
David Lacomis, University of Pittsburgh Identifier:
First received: October 8, 2009
Last updated: December 7, 2015
Last verified: December 2015
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 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
Genders Eligible for Study:   Both

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: December 7, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Paraneoplastic Syndromes
Paraneoplastic Syndromes, Nervous System
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Neurodegenerative Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Pathologic Processes
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Potassium Channel Blockers processed this record on May 26, 2016