Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01511978
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2011-12-24
Brief Title:
Effectiveness of 34-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome
Sponsor:
Jacobus Pharmaceutical
Organization:
Jacobus Pharmaceutical
Study Overview
Official Title:
Inpatient Double-Blind Placebo-Controlled Withdrawal Study of 34-Diaminopyridine Base 34-DAP in Subjects With Known Lambert-Eaton Myasthenic Syndrome
Status:
COMPLETED
Status Verified Date:
2017-07
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:
DAPPER
Brief Summary:
Hypothesis 34-Diaminopyridine base 34-DAP improves Lambert-Eaton Myasthenic Syndrome LEMS-related weakness
Detailed Description:
The objectives of the study were to confirm the safety and to test the efficacy of 34-DAP in the treatment of LEMS-related weakness
This was a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects with known clinically active LEMS who had been on a chronic stable dose of compassionate distribution Jacobus 34-DAP provided through FDA-approved individual investigator-held INDs
This was a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects with known clinically active LEMS who had been on a chronic stable dose of compassionate distribution Jacobus 34-DAP provided through FDA-approved individual investigator-held INDs
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