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

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ClinicalTrials.gov Identifier: NCT00872950
Recruitment Status : Recruiting
First Posted : April 1, 2009
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Lambert-Eaton Myasthenic Syndrome Congenital Myasthenic Syndrome Drug: 3,4-DIAMINOPYRIDINE Drug: 3,4-Diaminopyridine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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)
Study Start Date : June 2001
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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: Erin E Clark 781-744-2862 Erin.Clark@lahey.org
Contact: LeeAnne Lipert 781-744-8383 leeanne.lipert@lahey.org

Locations
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Erin E Clark    781-744-2862    erin.clark@lahey.org   
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Jayashri Srinivasan, MD, MCRP, PhD Lahey Clinic

Additional Information:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00872950     History of Changes
Other Study ID Numbers: 2001-040
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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