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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Lahey Clinic
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00872950
First received: March 30, 2009
Last updated: May 22, 2013
Last verified: May 2013

March 30, 2009
May 22, 2013
June 2001
June 2020   (final data collection date for primary outcome measure)
Increase in strength and autonomic symptoms [ Time Frame: 1-10 years ] [ Designated as safety issue: Yes ]
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 Provided
Intervention Model: Single Group Assignment
Masking: 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
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
Both
18 Years and older
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
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
May 2013

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