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New treatment option for Acute Ischemic Stroke
Official title Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
ClinicalTrials.gov ID: NCT06226805
What this study is testing
What is BB-031?
BB-031 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for acute ischemic stroke.
Also referred to as DTRI-031.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Burlingame, California, United States
- Long Beach, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Jacksonville, Florida, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Harlingen, Texas, United States
- Houston, Texas, United States
- New Lambton Heights, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Parkville, Victoria, Australia
- Murdoch, Western Australia, Australia
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Burlingame, California, United States; Long Beach, California, United States; San Francisco, California, United States; Torrance, California, United States; Jacksonville, Florida, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.