Trial record 15 of 76 for:    Paraneoplastic Syndromes

Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome (3 4-DAP)

Expanded access is currently available for this treatment.
Verified August 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01825395
First received: March 22, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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


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

Study Type: Expanded Access     What is Expanded Access?
Official Title: Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Study Start Date: July 2004
Estimated Study Completion Date: March 2050
Estimated Primary Completion Date: February 2050 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 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 past or current seizures, cardiac arrhythmia, hepatic, renal or hematologic disease or of severe asthma.
  • Is believed by the investigator to be unable to comply with the protocol.
  • Is unable to give informed consent.
  • Is pregnant.
  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: NCT01825395

Contacts
Contact: Kathy Ales 6099217447

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01825395     History of Changes
Other Study ID Numbers: 04-0567
Study First Received: March 22, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014