Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02090725
Status:
TERMINATED
Last Update Posted:
2019-05-21
First Post:
2014-03-14
Brief Title:
Controlled Trial of 34-Diaminopyridine 3-4DAP in Lambert-Eaton Myasthenic Syndrome LEMS
Sponsor:
Jeffrey A Cohen MD
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Controlled Trial of 34-Diaminopyridine in LEMS
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug receive FDA approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3-4DAP
Brief Summary:
The main purpose for this study is to provide access to 34 DAP a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome LEMS is a rare autoimmune cause of a defect in neuromuscular transmission The disorder is clinically characterized by fluctuating muscle weakness hyporeflexia and autonomic dysfunction
Detailed Description:
More than half of LEMS cases are associated with malignancy usually small cell lung cancer These paraneoplastic cases progress more quickly than primary autoimmune LEMS An overlap syndrome with other autoimmune diseases is often detected in LEMS patients
34 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential 34 DAP is less likely to provoke epileptic seizures than its precursor 4-aminopyridine because it is less able to cross the blood-brain barrier 34 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies
34 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential 34 DAP is less likely to provoke epileptic seizures than its precursor 4-aminopyridine because it is less able to cross the blood-brain barrier 34 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None