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3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS) (LEMS)

This study is currently recruiting participants.
Verified June 2016 by Lahey Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872950
First Posted: April 1, 2009
Last Update Posted: June 23, 2016
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.
Information provided by (Responsible Party):
Lahey Clinic
  Purpose
The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Increase in strength and autonomic symptoms [ Time Frame: 1-10 years ]

Estimated Enrollment: 25
Study Start Date: June 2001
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open label Drug: 3,4-DIAMINOPYRIDINE
Treatment will begin with a low dose and will be increased as clinically needed as tolerated. The upper limit will be a total of 100mg/day.
Other Name: 3,4 DAP
Drug: 3,4-Diaminopyridine
Other Name: 3,4-DAP

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis
  • 18 years or older
  • Females must have negative pregnancy test and be willing to practice an effective form of birth control
  • No prolonged QT syndrome as indicated by baseline EKG

Exclusion Criteria:

  • Known sensitivity to 3,4-DIAMINOPYRIDINE
  • History of seizures and/or severe asthma
  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): NCT00872950


Contacts
Contact: Nick F Ventura 781-744-3216 Nicholas.F.Ventura@lahey.org
Contact: Stephanie A Scala, MA 781-744-2950 stephanie.a.scala@lahey.org

Locations
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Lynn A Sullivan    781-744-2958    lynn.a.sullivan@lahey.org   
Contact: Stephanie A Scala, MA    781-744-2950    stephanie.a.scala@lahey.org   
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Jayashri Srinivasan, MD, MCRP, PhD Lahey Clinic
Study Director: H. Royden Jones, MD Lahey Clinic
  More Information

Additional Information:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00872950     History of Changes
Other Study ID Numbers: 2001-040
First Submitted: March 30, 2009
First Posted: April 1, 2009
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Lahey Clinic:
LEMS
CMS
3,4 DIAMINOPYRIDINE
3,4 DAP

Additional relevant MeSH terms:
Syndrome
Lambert-Eaton Myasthenic Syndrome
Myasthenic Syndromes, Congenital
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
Genetic Diseases, Inborn
3,4-diaminopyridine
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action