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Trial record 14 of 74 for:    Paraneoplastic Syndromes

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Expanded access is currently available for this treatment.
Verified October 2017 by David Lacomis, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994916
First Posted: October 14, 2009
Last Update Posted: October 13, 2017
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.
Collaborator:
Jacobus Pharmaceutical
Information provided by (Responsible Party):
David Lacomis, University of Pittsburgh
  Purpose
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.

  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00994916


Contacts
Contact: David Lacomis, MD 412-647-1706 lacomisd@upmc.edu

Sponsors and Collaborators
David Lacomis
Jacobus Pharmaceutical
  More Information

Responsible Party: David Lacomis, Professor of Neurology and Pathology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00994916     History of Changes
Other Study ID Numbers: IRB0410047
First Submitted: October 8, 2009
First Posted: October 14, 2009
Last Update Posted: October 13, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Syndrome
Lambert-Eaton Myasthenic Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Disease
Pathologic Processes
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
3,4-diaminopyridine
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action