A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Ph… (NCT07742098) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke
140 participantsStarted 2026-10-31
Plain-language summary
This is a trial to evaluate the safety and effect of three intravenous (IV) doses of NTS-521 for the early recovery treatment of acute ischemic stroke (AIS). Participants will be followed for 90 days.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute ischemic stroke with moderate to severe hemiparesis
* Functional independence in activities of daily living without requiring nursing care before the index stroke.
* Consent process by participant or proxy, with reconsent provision.
* Age ≥ 45 to ≤ 80 years of age (inclusive) on the date of randomization
* Sufficient attention, comprehension, and cooperation to carry out instructions
Exclusion Criteria:
* Pre-existing motor deficit prior to index stroke
* Posterior circulation ischemic stroke
* Lacunar stroke
* Qualifying brain imaging demonstrating intracranial hemorrhage, malignant middle cerebral artery (MCA) infarct with edema, or bilateral/multifocal infarcts, clinically significant vascular malformation, brain tumor, or other central nervous system (CNS) pathology
* Recent major surgery or trauma (\<30 days)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still in Phase 2a and hasn't started enrolling yet — does that mean there's very little human safety data on NTS-521 so far, and how does that uncertainty compare to the standard treatments I'd be receiving for my stroke recovery?
2Since the trial is giving NTS-521 as an intravenous infusion, what does that actually involve for someone in early stroke recovery — how many infusions, how often, and would I need to stay in the hospital or travel to a study site during a time when I'm still recovering?
3The main thing this trial is measuring is safety, not whether NTS-521 improves recovery outcomes — so realistically, what might I personally gain by participating, versus what risks would I be taking on?
4Because this trial isn't recruiting yet, if I might be a candidate, how long could I realistically be waiting before it opens, and would that delay affect my window for standard stroke rehabilitation or other treatments?
5Are there standard-of-care options or other studies already further along in testing that might be worth considering first, given that this is an early-phase trial where the dose-response is still being worked out?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Assessment
Timeframe: Safety assessments between baseline and Day 30 and Day 90