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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00056238
First received: March 7, 2003
Last updated: June 23, 2005
Last verified: March 2003
  Purpose

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.


Condition Intervention Phase
Stroke
Neurologic Diseases, General
Drug: NC-758 (Anti amyloidotic [Aß] agent)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bellus Health Inc:

Estimated Enrollment: 30
Study Start Date: February 2003
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056238

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Bellus Health Inc
Investigators
Principal Investigator: Steven M. Greenberg, M.D., PhD. Massachusetts General Hospital
Investigator: Co-sponsor: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA
  More Information

Publications:
M.C. Belanger, P. Krzywkowski, J. Paquette, M. Yu, C. Ramassamy, P. Tremblay, and F. Gervais. Development of Cerebral Amyloid Angiopathy in the TgCRND8 Mouse Model of Alzheimer's Disease. Data presented at the Society for Neuroscience, Orlando, FL, November 2002.

ClinicalTrials.gov Identifier: NCT00056238     History of Changes
Other Study ID Numbers: CL-758003
Study First Received: March 7, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Bellus Health Inc:
Neurologic Diseases (General)
Hemorrhagic Stroke
Cerebral Amyloid Angiopathy
Cerebrovascular Accident

Additional relevant MeSH terms:
Cerebral Amyloid Angiopathy
Hemorrhage
Nervous System Diseases
Stroke
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014