Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BB-031, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients
Overview
The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. 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.
Detailed description
This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 180 participants will be randomized to receive a single dose of two sequential dose levels of study drug or placebo.
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.
Interventions
- Drug BB-031
Solution for injection - Drug Placebo
0.9% sodium chloride for injection
Primary outcome measures
- Symptomatic Intracranial Hemorrhage (sICH) [Time frame: 24 hours]
Secondary outcome measures (2)
- Asymptomatic intracranial hemorrhage (non-symptomatic-ICH) [Time frame: 24 hours]
- Adverse Events (AEs) [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of acute ischemic stroke
- 18 years or older
- Anterior circulation intra-cranial occlusion
- NIHSS score >3
- Onset of stroke symptoms within 24 hours of enrollment
Exclusion criteria
- Large volume ischemic stroke
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 15 centers
- HonorHealth Bob Bove Neuroscience Institute — Scottsdale
- Mills Peninsula Medical Center — Burlingame
- MemorialCare Long Beach Medical Center — Long Beach
- California Pacific Medical Center — San Francisco
- Pacific Neurosciences Institute at Saint John's Physician Partners — Torrance
- Baptist Health Medical Center — Jacksonville
- Henry Ford Hospital — Detroit
- Washington University in St. Louis — St Louis
- … and 7 more centers
Australia · 6 centers
- John Hunter Hospital — New Lambton Heights
- Princess Alexandra Hospital — Woolloongabba
- Royal Adelaide Hospital — Adelaide
- Monash Medical Centre — Clayton
- The Royal Melbourne Hospital — Parkville
- Fiona Stanley Hospital — Murdoch
Canada · 4 centers
- University of Calgary — Calgary
- University of Alberta Hospital — Edmonton
- Vancouver Stroke Program — Vancouver
- Ottawa Hospital Research Institute — Ottawa
Identifiers
NCT: NCT06226805 · BB-031-CLIN-201