Search / Trial NCT06226805

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

Launched by BASKING BIOSCIENCES, INC. · Jan 17, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Stroke Wake Up Stroke Large Vessel Occlusion Intracranial Hemorrhage

ClinConnect Summary

The RAISE study is a clinical trial designed to test a new medication called BB-031 in patients who have experienced an acute ischemic stroke, which is a type of stroke caused by a blockage in blood flow to the brain. The trial aims to find out if different doses of BB-031 are safe and well-tolerated in patients who have had a stroke within the last 24 hours. A total of 156 participants are expected to join, and they will be randomly assigned to receive either the new drug or a placebo (a dummy treatment) for 90 days.

To join the study, participants must be at least 18 years old and have a specific type of blockage in the brain's blood vessels. However, certain people will not be eligible, including those with very large strokes, recent bleeding in the brain, or specific health conditions that put them at higher risk for bleeding. Throughout the trial, participants will receive close monitoring to ensure their safety and to gather important information about how well the medication works. If you or someone you know has had a stroke recently and is interested in participating, this study could be an opportunity to contribute to valuable research.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Clinical diagnosis of acute ischemic stroke
  • 18 years or older
  • Anterior circulation intra-cranial occlusion
  • 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

Trial Officials

Michael D Hill, MD

Principal Investigator

University of Calgary

Shahid M Nimjee, MD, PhD

Principal Investigator

Ohio State University

About Basking Biosciences, Inc.

Basking Biosciences, Inc. is an innovative clinical trial sponsor dedicated to advancing healthcare through the development of novel therapeutics and cutting-edge biotechnologies. With a focus on addressing unmet medical needs, the company leverages a robust pipeline of drug candidates targeting various disease areas, including oncology and rare diseases. Basking Biosciences is committed to conducting rigorous clinical research while adhering to the highest standards of regulatory compliance and ethical practices. Through strategic collaborations and a patient-centered approach, the company aims to bring transformative solutions to patients and improve outcomes in the healthcare landscape.

Locations

Columbus, Ohio, United States

Parkville, Victoria, Australia

Jacksonville, Florida, United States

San Francisco, California, United States

Burlingame, California, United States

Long Beach, California, United States

Toledo, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0