J147 for Stroke
(JUMPSTART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new drug, J147, can improve recovery after an ischemic stroke, which occurs when a blood clot blocks blood flow to the brain. Participants will receive J147 by injection (emulsion for injection), and researchers will compare their recovery to those who do not receive the drug. The trial will also assess the drug's safety by monitoring brain scans and blood samples. Ideal candidates are those who have recently experienced a stroke requiring a clot-removal procedure and are not receiving other clot-busting treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in stroke recovery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that J147 is generally safe for humans. Early studies suggest it maintains a good safety record. For instance, tests found that J147 caused negative effects on cells only at very high doses, exceeding those used in treatment. In studies with healthy individuals, J147 did not exhibit any obvious harmful effects. Additionally, J147 appears to protect the brain by reducing the risk of bleeding after a stroke, potentially lowering the chances of death from a stroke. While these results are promising, ongoing trials must continue to study how well people tolerate J147.12345
Why are researchers excited about this trial's treatment?
Unlike standard treatments for stroke, such as clot-busting drugs like tPA or mechanical thrombectomy, J147 is unique because it is derived from an active ingredient initially developed for Alzheimer's disease. Researchers are excited about J147 because it targets cellular aging and inflammation, which are crucial in stroke recovery. This new approach could potentially improve brain repair and recovery after a stroke, offering hope for a more effective treatment. Additionally, J147 is administered as an emulsion for injection, which might enhance its delivery and effectiveness in targeting acute stroke damage.
What evidence suggests that J147 could be an effective treatment for stroke?
Research has shown that J147, which participants in this trial may receive, may aid recovery from an ischemic stroke. Studies have found that J147 significantly reduces brain damage when administered soon after a stroke. In animal tests, it decreased the size of the brain injury, suggesting it might help limit stroke damage. J147 also protects brain cells and improves blood flow in the brain, potentially supporting better recovery after a stroke.12367
Who Is on the Research Team?
Marguerite Prior, Ph.D.
Principal Investigator
Abrexa Pharmaceuticals, Inc.
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?
This trial is for adults who recently had an ischemic stroke with significant symptoms, have good recovery potential before the stroke, and received successful clot removal treatment within 24 hours. Participants must be able to give consent or have a representative do so.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous bolus injection of J147 or placebo following mechanical thrombectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI scans and blood sample collection
What Are the Treatments Tested in This Trial?
Interventions
- J147 Emulsion for Injection
- Placebo
Trial Overview
The study tests if J147, given by injection after blood clot removal in stroke patients, improves recovery compared to a placebo. Participants are randomly assigned to receive either J147 or placebo and will undergo several brain scans and blood tests.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
J147 Emulsion for Injection
J147 Emulsion for Injection, 1.6 mg/kg
J147 Emulsion for Injection, 2.5 mg/kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abrexa Pharmaceuticals, Inc.
Lead Sponsor
IQVIA RDS Inc.
Industry Sponsor
Citations
J147 Reduces tPA-Induced Brain Hemorrhage in Acute ... - PMC
Results. We found that J147 treatment significantly reduced infarct volume when administered at 2 h after stroke onset in the tMCAO model, but had no effect in ...
J147 Reduces tPA-Induced Brain Hemorrhage in Acute ...
Results: We found that J147 treatment significantly reduced infarct volume when administered at 2 h after stroke onset in the tMCAO model, but ...
Safety and Efficacy of J147 in Acute Ischemic Stroke
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 ...
4.
researchgate.net
researchgate.net/publication/358977504_J147_Reduces_tPA-Induced_Brain_Hemorrhage_in_Acute_Experimental_Stroke_in_RatsJ147 Reduces tPA-Induced Brain Hemorrhage in Acute ...
Results We found that J147 treatment significantly reduced infarct volume when administered at 2 h after stroke onset in the tMCAO model, but ...
J147 for Stroke (JUMPSTART 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 ...
J-147 a Novel Hydrazide Lead Compound to Treat ... - PMC
The CeeTox panel shows that J-147 produced some adverse effects on cellular activities, in particular mitochondrial function, but only with high concentrations ...
NCT03838185 | Study to Assess the Safety, Tolerability ...
Healthy young male subjects will receive a single ascending oral dose of J147 following an overnight fast of at least 8 hours. Healthy elderly subjects will ...
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