Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190268
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2005-09-13
Brief Title:
Efficacy of 34-DAP in Fatigue Associated With Multiple Sclerosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multicentric Study Comparative Randomized in Double Knowledge of the Effectiveness Versus Placebo of a Salt Of 34 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Rational of study 34-diaminopyridine is suspected to improved the fatigue associated in patients multiple sclerosis
In order to confirm this hypothesis a randomized controlled versus placebo double blinded study is performed
In order to confirm this hypothesis a randomized controlled versus placebo double blinded study is performed
Detailed Description:
We proposed a randomized controlled trial between 34-diaminopyridine and placebo
The main objective improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm The hypothesis tested is that the 34-DAP is efficacy in the fatigue of multiple sclerosis
The main objective improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm The hypothesis tested is that the 34-DAP is efficacy in the fatigue of multiple sclerosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None