Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
NCT ID: NCT06226805
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
228 participants
INTERVENTIONAL
2024-07-31
2027-09-30
Brief Summary
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Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.
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Detailed Description
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All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study as outlined in the protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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BB-031
A single dose of BB-031 will be administered via IV bolus injection
BB-031
Solution for injection
Placebo
A single dose of matching placebo will be administered via IV bolus injection
Placebo
0.9% sodium chloride for injection
Interventions
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BB-031
Solution for injection
Placebo
0.9% sodium chloride for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Anterior circulation intra-cranial occlusion
* NIHSS score \>3
* Onset of stroke symptoms within 24 hours of enrollment
Exclusion Criteria
* Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
* Chronic intracranial occlusion
* Weight \>125kg
* Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
* Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
* Prior stroke within 90 days
* Unable to undergo a contrast brain perfusion scan with either MRI or CT
18 Years
ALL
No
Sponsors
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Basking Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael D Hill, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Shahid M Nimjee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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HonorHealth Bob Bove Neuroscience Institute
Scottsdale, Arizona, United States
Mills Peninsula Medical Center
Burlingame, California, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
California Pacific Medical Center
San Francisco, California, United States
Pacific Neurosciences Institute at Saint John's Physician Partners
Torrance, California, United States
Baptist Health Medical Center
Jacksonville, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
WakeMed
Raleigh, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Other Identifiers
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BB-031-CLIN-201
Identifier Type: -
Identifier Source: org_study_id
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