StrokePhase 2NCT00056238
Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy
A Phase 2 study testing NC-758 (Anti amyloidotic [Aß] agent) in people with Stroke and Neurologic Diseases, General, run by Bellus Health Inc. - a GSK company at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Neurologic Diseases, General
- What is being tested?
- NC-758 (Anti amyloidotic [Aß] agent)
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Cincinnati
Cincinnati, Ohio, 45267
University of Kentucky
Lexington, Kentucky, 40506
Columbia University
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the 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
- Stroke, Neurologic Diseases, General
- Being tested
- NC-758 (Anti amyloidotic [Aß] agent)
- Keywords
- Neurologic Diseases (General), Hemorrhagic Stroke, Cerebral Amyloid Angiopathy, Cerebrovascular Accident
- Medical subject headings
- Stroke, Nervous System Diseases, Hemorrhagic Stroke, Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC-758 (Anti amyloidotic [Aß] agent)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2003 (estimated)
- Study startFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven M. Greenberg, M.D., PhD., Principal investigator, Massachusetts General HospitalCo-sponsor: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056238
- Sponsor's protocol ID
- CL-758003
- Status last verified
- Mar 2003
- First submitted
- 7 Mar 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 11676287M.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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00056238
- Acronym / sponsor ID
- CL-758003
- Conditions
- Stroke, Neurologic Diseases, General
- Keywords
- Neurologic Diseases (General), Hemorrhagic Stroke, Cerebral Amyloid Angiopathy, Cerebrovascular Accident
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2003
- First posted
- 10 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC-758 (Anti amyloidotic [Aß] agent) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 11676287Gervais 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.
- BackgroundM.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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M. Greenberg, M.D., PhD. principal investigator
Massachusetts General Hospital
Co-sponsor: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NC-758 (Anti amyloidotic [Aß] agent) in people with Stroke and Neurologic Diseases, General, run by Bellus Health Inc. - a GSK company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.