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

Descriptive Information
Brief Title † 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
Official Title † Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)
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).
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Increase in strength and autonomic symptoms
Secondary Outcome Measure †
Condition † Lambert-Eaton Myasthenic Syndrome Congenital Myasthenic Syndrome
Intervention † Drug3,4-DIAMINOPYRIDINE
Study Arms / Comparison Groups Open label
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 25
Start Date † June 2001
Completion Date June 2020
Primary Completion Date June 2020
Eligibility 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Nick F Ventura, 781-744-3216, Nicholas.F.Ventura@lahey.org
Location Countries † United States
Administrative Information
NCT ID † NCT00872950
Organization ID 2001-040
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Lahey Clinic
Collaborators ††
Investigators † Principal Investigator: Jayashri Srinivasan, MD, MCRP, PhD, Lahey Clinic
Information Provided By
Verification Date July 2015
First Received Date † March 30, 2009
Last Updated Date July 14, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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