Clinical Trial: Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Bellus Health Inc

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bellus Health Inc

Dates:
Date Received: March 7, 2003
Date Started: February 2003
Date Completion:
Last Updated: June 23, 2005
Last Verified: March 2003