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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 : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

March 30, 2009
April 1, 2009
January 12, 2018
June 2001
June 2020   (Final data collection date for primary outcome measure)
Increase in strength and autonomic symptoms [ Time Frame: 1-10 years ]
Same as current
Complete list of historical versions of study NCT00872950 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)
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).
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lambert-Eaton Myasthenic Syndrome
  • Congenital Myasthenic Syndrome
  • 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
Open label
Interventions:
  • Drug: 3,4-DIAMINOPYRIDINE
  • Drug: 3,4-Diaminopyridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
4
June 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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
United States
 
 
NCT00872950
2001-040
No
Not Provided
Not Provided
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Jayashri Srinivasan, MD, MCRP, PhD Lahey Clinic
Study Director: H. Royden Jones, MD Lahey Clinic
Lahey Clinic
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP