Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190047
Status:
COMPLETED
Last Update Posted:
2007-11-26
First Post:
2005-09-11
Brief Title:
Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke
Sponsor:
D-Pharm Ltd
Organization:
D-Pharm Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Parallel Study To Evaluate The Effects Of DP-b99 On Neurologic Function And Disability In Subjects With Acute Ischemic Hemispheric Stroke
Status:
COMPLETED
Status Verified Date:
2007-11
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:
This study will examine if DP-b99 can improve neurological function for example strength and coordination in the 3 months after an acute stroke
Detailed Description:
The study will include a ScreeningBaseline Period a Treatment Period and a Post-treatment Follow-up Period During the Screening Period subjects will be selected for the study on the basis of inclusion and exclusion criteria see below A screening computed tomography scan to exclude brain bleeding will be performed The patients informed consent will be obtained The patient will be randomly allocated to DP-b99 or placebo Immediately after this randomization and baseline assessments lab tests and ECG subjects will be given a 2-hour intra-venous infusion of DP-b99 or placebo Additional 3 such infusions will then be given daily to a total of 4 consecutive treatment days which make up the Treatment Period Throughout the 4-day Treatment Period the treatments safety and the National Institutes of Health Stroke Scale NIHSS score will be evaluated daily The NIHSS assesses certain abilities of the patient eg strength speech vision and coordination If their condition requires patients may have to stay in hospital more than these 4 days regardless of their participation in the studySubjects will be further assessed for NIHSS score changes and safety lab tests and ECG during the Post-treatment Follow-up Period with data collected 30 and 90 days after the stroke Other outcome scales Barthel Index and Modified Rankin Scale will be also used in the Day 30 and Day 90 visits
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