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J147 for Stroke

(JUMPSTART Trial)

MP
Overseen ByMarguerite Prior, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Abrexa Pharmaceuticals, Inc.
Must not be taking: Thrombolytics
Disqualifiers: Renal insufficiency, Hepatic impairment, others
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to find out if the drug J147 improves outcomes for persons who have had an ischemic stroke. It also will learn about the safety of J147 when given by injection to stroke patients. Researchers will compare the outcomes of those who receive J147 after therapy to clear the blood clot to those who don't receive J147. Participants will be asked to undergo a series of three to four magnetic resonance imaging (MRI) brain scans, and blood samples will be collected at several time points. Participants will also be evaluated to measure several aspects of brain function.

Who Is on the Research Team?

MP

Marguerite Prior, Ph.D.

Principal Investigator

Abrexa Pharmaceuticals, Inc.

SJ

Steven J Warach, MD, PhD

Principal Investigator

Dell Seton Medical Center at the University of Texas at Austin

Are You a Good Fit for This Trial?

Inclusion Criteria

* eTICI or better reperfusion achieved after completion of EVT.
* Signed informed consent obtained from the patient or legally authorized representative.
I use combined hormonal birth control with estrogen and progestogen.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous bolus injection of J147 or placebo following mechanical thrombectomy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and blood sample collection

90 days
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • J147 Emulsion for Injection
  • Placebo

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Target Dose J147Experimental Treatment1 Intervention
Group II: Low Dose J147Experimental Treatment1 Intervention
Group III: High Dose J147Experimental Treatment1 Intervention
Group IV: High Dose PlaceboPlacebo Group1 Intervention
Group V: Target Dose PlaceboPlacebo Group1 Intervention
Group VI: Low Dose PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abrexa Pharmaceuticals, Inc.

Lead Sponsor

Trials
1
Recruited
60+

IQVIA RDS Inc.

Industry Sponsor

Trials
7
Recruited
14,700+

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