Trial studying safety and effects for Acute Ischemic Stroke
Official title Safety and Efficacy of J147 in Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT07430917
What this study is testing
What is J147 Emulsion for Injection?
J147 Emulsion for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Signed informed consent obtained from the patient or legally authorized representative.
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS ≥5 and ≤25 points obtained prior to randomization with a disabling neurological deficit as determined by clinical judgement.
- Pre-stroke mRS score of 0-2.
- Availability to be treated within 24 hours of last known well.
You likely can't join if
- Absolute contraindication to MRI with gadolinium contrast.
- Serious, advanced, or terminal illness with an anticipated life expectancy of \<6 months.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) of \<30 mL/min.
- Clinically significant hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper level of normal...
- Patients that have received intravenous or intra-arterial thrombolytic for the current stroke prior to mechanical thrombectomy.
See the full eligibility criteria
- Signed informed consent obtained from the patient or legally authorized representative.
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS ≥5 and ≤25 points obtained prior to randomization with a disabling neurological deficit as determined by clinical judgement.
- Pre-stroke mRS score of 0-2.
- Availability to be treated within 24 hours of last known well.
- Candidates to receive EVT treatment without IV thrombolytic therapy. Such patients should be initiated as recommended by the local standard of care for the early management of patients with AIS.
- eTICI or better reperfusion achieved after completion of EVT.
- Females, unless they are permanently sterile (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal (defined as no menses for at least 12 consecutive months without an alternative...
- Combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal, or injectable).
- Progestogen-only hormonal contraception (oral, injectable, or implantable).
- Intrauterine device (IUD).
- Intrauterine hormone-releasing system (IUS).
- Bilateral tubal occlusion.
- Sexual abstinence, if consistent with the participant's usual lifestyle.
- Vasectomized partner, provided the partner is the sole sexual partner and the vasectomy has been confirmed with a negative sperm count.
- Barrier methods (e.g., condoms with spermicide, diaphragms) are not considered highly effective and should only be used as additional protection.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test before enrollment.
- Male participants with WOCBP partners must either:
- Be vasectomized, or
- Agree to use condoms with spermicide plus an additional highly effective method of contraception used by the female partner, during the study and for 30 days after the last dose of study drug.
- Men must also agree not to donate sperm during the study and for the same period post-treatment. Specific Neuroimaging Occlusion of an internal carotid, middle cerebral, anterior cerebral, posterior cerebral artery...
- MRI criterion: volume of DWI ≥5 and ≤70 mL determined by any validated, automated artificial intelligence (AI) thresholding estimates of core and penumbra for participant selection and mismatch volume at least 25 mL...
- Absolute contraindication to MRI with gadolinium contrast.
- Serious, advanced, or terminal illness with an anticipated life expectancy of \<6 months.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) of \<30 mL/min.
- Clinically significant hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper level of normal (ULN) and/or total bilirubin \>1.5× ULN, unless attributable to a known...
- Patients that have received intravenous or intra-arterial thrombolytic for the current stroke prior to mechanical thrombectomy.
- Patients participating in a study involving an investigational drug or device.
- Any clinically significant medical history, physical examination finding, laboratory abnormality, vital sign abnormality, or 12-Lead ECG finding that, in the opinion of the investigator, may pose a risk to the patient's...
- Patients that are unlikely to be available for a 90-day follow up.
- Female patients who are pregnant or lactating or are unwilling to use effective methods of contraception.
- Patients with known adverse reaction to J147 or its components.
- Patients previously enrolled in this clinical study. Specific Neuroimaging Exclusion Criteria
- Computed tomography (CT) or MRI evidence of acute intracranial hemorrhage (the presence of chronic microbleeds is allowed).
- Significant mass effect with midline shift.
- Imaging evidence or history of intracranial neoplasms except for meningiomas.
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Rockford, Illinois, United States
- Albany, New York, United States
- Portland, Oregon, United States
- Austin, Texas, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Rockford, Illinois, United States; Albany, New York, United States; Portland, Oregon, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.