Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056238
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-03-07
Brief Title:
Cerebril in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
Sponsor:
Bellus Health Inc - a GSK company
Organization:
Bellus Health Inc - a GSK company
Study Overview
Official Title:
A Phase II Pilot Study of the Safety Tolerability and Pharmacokinetics of Cerebril in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
Status:
COMPLETED
Status Verified Date:
2003-03
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:
None
Brief Summary:
The main objective of this study is to evaluate the safety tolerability and pharmacokinetics of Cerebril in Cerebral Amyloid Angiopathy CAA patients who have had lobar cerebral hemorrhage
Detailed Description:
Hemorrhagic Stroke due to CAA represents approximately 7 of all strokes
The current phase II clinical study investigates the safety tolerability pharmacokinetic and pharmacodynamic profiles of the drug candidate in patients who have suffered lobar hemorrhages The initial phase of the study is also aimed at determining the optimal dosing regimens for subsequent drug candidate efficacy trials The trial is also evaluating the appearance of new cerebral hemorrhages on gradient-echo MRI scans the amyloid ß Aß protein levels in the plasma and cerebrospinal fluid and the neurological and cognitive functions
The current phase II clinical study investigates the safety tolerability pharmacokinetic and pharmacodynamic profiles of the drug candidate in patients who have suffered lobar hemorrhages The initial phase of the study is also aimed at determining the optimal dosing regimens for subsequent drug candidate efficacy trials The trial is also evaluating the appearance of new cerebral hemorrhages on gradient-echo MRI scans the amyloid ß Aß protein levels in the plasma and cerebrospinal fluid and the neurological and cognitive functions
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