Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00994916
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-07-09
First Post:
2009-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Sponsor:
David Lacomis, MD
Organization:
Study Overview
Official Title:
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
Detailed Description:
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.
The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.
The investigator has a hold on enrolling new subjects.
The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.
The investigator has a hold on enrolling new subjects.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: