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

Completed · Phase 2

Conditions studied: Stroke, Neurologic Diseases, General

In brief

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.

Key facts

Study ID

NCT00056238

Run by

Bellus Health Inc. - a GSK company

People needed

30

Starts

2003-02-01

Last updated by the study team

2005-06-24

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be 55 years of age or older.
• Males and females. Females must be of non-childbearing potential (i.e. surgically sterilized or at least one year post-menopausal).
• Diagnosis of possible or probable CAA based on the Boston Criteria for Diagnosis of CAA-Related Hemorrhage.
• Nonfatal lobar hemorrhage (defined as hemorrhage in the cerebral cortex and underlying white matter sparing the basal ganglia and thalamus) within previous five years diagnosed by CT or MRI scan.
• Patient has no intent to donate blood for 4 weeks after completion of the study.
• Signed informed consent.

You may not qualify if…

• Other established causes of hemorrhage at the time of the index hemorrhage event. Exclusion causes include excessive anticoagulation (INR > 4.0), associated head trauma or ischemic stroke, CNS tumor, vascular malformation, vasculitis, and blood dyscrasia.
• Patient with a clinically significant and uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, hematological condition or other significant medical disease.
• Presence of any condition that could interfere with the interpretation of study results or compromise patient safety.
• Debilitated neurological state or other known disease likely to result in early death.
• Disability characterized by a modified Rankin score ≥ 4.
• ALT, ALP, AST or total bilirubin ≥ 1.5 the upper limit of normal ranges.
• Contraindications to MRI scan (e.g. cranial metallic implant, cardiac pacemaker, and severe claustrophobia).
• Allergy and/or hypersensitivity to analgesic agents used for the lumbar puncture (for patients undergoing lumbar puncture only).
• Allergy and/or hypersensitivity to any component of the study medication.
• Use of an investigational drug within 30 days prior to Screening visit.
• Use of warfarin or warfarin containing compounds and heparin or heparin containing compounds within 7 days prior to Baseline (Week 0) visit.
• Diagnosis of cystatin C amyloid angiopathy.
• Active alcohol and/or drug abuse.
• Inability to provide legal consent

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Columbia University — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.