Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
- Conditions
- StrokeNeurologic Diseases, General
- Registration Number
- NCT00056238
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Columbia University
🇺🇸New York, New York, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States