RECRUITING

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

Conditions

Acute Ischemic Stroke Stroke Wake-up stroke Large vessel occlusion Intracranial hemorrhage

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-31

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06226805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Program Director

CONTACT

9196184721

snelson@baskingbiosciences.com

Principal Investigator

Michael D Hill, MD

PRINCIPAL_INVESTIGATOR

University of Calgary

Shahid M Nimjee, MD, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

Mills Peninsula Medical Center

Burlingame, California, 94010

United States

MemorialCare Long Beach Medical Center

Long Beach, California, 90806

United States

California Pacific Medical Center

San Francisco, California, 94109

United States

Providence Little Company of Mary Medical Center

Torrance, California, 90503

United States

Baptist Health Medical Center

Jacksonville, Florida, 32207

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

WakeMed

Raleigh, North Carolina, 27610

United States

HonorHealth Bob Bove Neuroscience Institute

Scottsdale, North Carolina, 85251

United States

The Ohio State University

Columbus, Ohio, 43210

United States

ProMedica Toledo Hospital

Toledo, Ohio, 43604

United States

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, 78550

United States

Collaborators and Investigators

Sponsor: Basking Biosciences, Inc.

Michael D Hill, MD, PRINCIPAL_INVESTIGATOR, University of Calgary
Shahid M Nimjee, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-07-31

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Stroke
Wake-up stroke
Large vessel occlusion
Intracranial hemorrhage

Additional Relevant MeSH Terms

Acute Ischemic Stroke