Evaluating BB-031 for patients with acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and tolerability of the investigational drug BB-031 in patients diagnosed with acute ischemic stroke within 24 hours of symptom onset. It consists of two parts: the first part involves ascending doses of the drug to determine optimal dosing, while the second part involves a randomized comparison of selected doses against a placebo. A total of 156 participants will be followed for 90 days, with outcomes evaluated by a central blinded reviewer. The study is designed to provide insights into the drug's efficacy and safety profile in this patient population.

Why it matters

Who can join: the full rules

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 CTA or MRA
* Known severe renal disease
* Known hypersensitivity to any constituent of BB-031

Where it's running

• HonorHealth Bob Bove Neuroscience Institute
  Scottsdale, Arizona, United States Recruiting
• Pacific Neurosciences Institute at Saint John's Physician Partners
  Torrance, California, United States Recruiting
• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• Cooper University Hospital
  Camden, New Jersey, United States Recruiting
• WakeMed
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Michael D Hill, MD — University of Calgary
• Study coordinator: Program Director
• Email: snelson@baskingbiosciences.com
• Phone: 9196184721

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mobilisation After Endovascular Stroke Treatment

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• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

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  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.