Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331721
Status:
TERMINATED
Last Update Posted:
2008-05-22
First Post:
2006-05-30
Brief Title:
Tolerability of Enecadin INN in Acute Ischemic Stroke Trial - TEST
Sponsor:
PAION Deutschland GmbH
Organization:
PAION Deutschland GmbH
Study Overview
Official Title:
A Multicentre Double-Blind Randomised Placebo-Controlled Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin INN in Acute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Scientific data called into question the viability of the substance class
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke Furthermore the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed Efficacy trends will be evaluated up to day 30 post stroke
Detailed Description:
In the acute stage of ischemic stroke an ischemic core characterized by a marked decrease in blood flow is present leading to irreversible neuronal damage at an early stage Around the boundary of the ischemic core there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset even though the blood flow is markedly decreased Prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke
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