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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bellus Health Inc
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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