Trials / Completed
CompletedNCT00056238
Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- Bellus Health Inc. - a GSK company · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NC-758 (Anti amyloidotic [Aß] agent) |
Timeline
- Start date
- 2003-02-01
- First posted
- 2003-03-10
- Last updated
- 2005-06-24
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00056238. Inclusion in this directory is not an endorsement.