Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004832
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Randomized Study of 34-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate the safety and effectiveness of 34-diaminopyridine DAP in the treatment of patients with Lambert-Eaton myasthenic syndrome LEMS
II Determine the side-effects and benefits associated with DAP
II Determine the side-effects and benefits associated with DAP
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to receive 34-diaminopyridine DAP or placebo orally 3 times daily for 5 days after which treatment is discontinued and patients are observed for at least 24 hours At the end of the blinded study patients may then elect to take open label DAP orally 3 times daily for 6 months those who do so are monitored for clinical effects and side effects for at least 6 months
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DUMC-FDR001068 | None | None | None |
| DUMC-577 | None | None | None |