Trial record 20 of 113 for:    "Expanded Access" [STUDY-TYPES] | Open Studies

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Available
Sponsor:
Collaborator:
Jacobus Pharmaceutical
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00994916
First received: October 8, 2009
Last updated: February 22, 2011
Last verified: February 2011
  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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00994916

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

Sponsors and Collaborators
University of Pittsburgh
Jacobus Pharmaceutical
  More Information

No publications provided

Responsible Party: David Lacomis, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00994916     History of Changes
Other Study ID Numbers: IRB0410047
Study First Received: October 8, 2009
Last Updated: February 22, 2011
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, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014