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

Primary Purpose

Stroke, Neurologic Diseases, General

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NC-758 (Anti amyloidotic [Aß] agent)
Sponsored by
Bellus Health Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neurologic Diseases (General), Hemorrhagic Stroke, Cerebral Amyloid Angiopathy, Cerebrovascular Accident

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky
  • Massachusetts General Hospital
  • Columbia University
  • University of Cincinnati
  • Thomas Jefferson University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2003
Last Updated
June 23, 2005
Sponsor
Bellus Health Inc
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00056238
Brief Title
Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bellus Health Inc
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neurologic Diseases, General
Keywords
Neurologic Diseases (General), Hemorrhagic Stroke, Cerebral Amyloid Angiopathy, Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NC-758 (Anti amyloidotic [Aß] agent)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Greenberg, M.D., PhD.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Co-sponsor: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11676287
Citation
Gervais F, Chalifour R, Garceau D, Kong X, Laurin J, Mclaughlin R, Morissette C, Paquette J. Glycosaminoglycan mimetics: a therapeutic approach to cerebral amyloid angiopathy. Amyloid. 2001 Jul;8 Suppl 1:28-35.
Results Reference
background
Citation
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.
Results Reference
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Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy

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