Acute Ischemic StrokePhase 2ACT-IVATENCT07742098
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
A Phase 2 study testing NTS-521 in people with Acute Ischemic Stroke, run by NeuroTrauma Sciences, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- NTS-521
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 15 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Domain Within the ACT-GLOBAL Trial Platform, 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
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.
Read the detailed description
Stroke represents a major global public health crisis, characterized by a paradox: declining age-standardized rates yet a rapidly expanding absolute global burden. According to recent epidemiological analyses from the Global Burden of Disease (GBD) study there were 11.9 million incident strokes worldwide in 2021, corresponding to a global age-standardized incidence rate of 141.5 per 100,000 person-years. Stroke claimed 7.3 million lives (an age-standardized mortality rate of 87.4 per 100,000), making it the third leading cause of mortality worldwide, accounting for 10.7% of all deaths.
The trial's target population for NTS-521 intervention consists of participants undergoing endovascular thrombectomy (EVT), and/or intravenous thrombolysis (IVT), or medical care without reperfusion treatment.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NTS-521, Placebo Control
- Keywords
- Acute Ischemic Stroke, AIS, Ischemic Stroke, Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTS-521Drug
Intravenous NTS-521
Placebo ControlOther
0.9% saline solution delivered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Placebo 0.9% saline solution | Placebo comparator | 0.9% saline solution Receives: Other: Placebo Control |
| Low Dose NTS-521 | Experimental | Low Dose NTS-521 in 0.9% saline delivered IV Receives: Drug: NTS-521 |
| Medium Dose NTS-521 | Experimental | Medium Dose NTS-521 in 0.9% saline delivered IV Receives: Drug: NTS-521 |
| High Dose NTS-521 | Experimental | High Dose NTS-521 in 0.9% saline delivered IV Receives: Drug: NTS-521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
Count of incident adverse events by treatment arm, including Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reaction (SUSARs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI - CTCAE v6.0), Vital signs and electrocardiograph (ECG) assessed by descriptive statistics, shift tables, and normal range criteria, and standard biochemical and hematology laboratory panel, assessed by descriptive statistics, shift tables, and normal range criteria
Measured: Safety assessments between baseline and Day 30 and Day 90
Secondary outcomes (4)
Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)
Change from baseline to Day 90 in the FMA-UE motor score (0-66; higher is better)
Measured: Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
National Institutes of Health Stroke Scale Assessment (NIHSS)
National Institutes of Health Stroke Scale (0-42; higher is worse)
Measured: Assessed as a continuous variable from baseline to Day 90
Modified Rankin Score (mRS)
Modified Rankin Score (mRS) (0-6; higher is worse), assessed as an ordinal variable
Measured: Assessed as an ordinal variable from Baseline to Day 90
EuroQual-5D-5L Assessment (EQ-5D-5L)
Change from baseline to Day 90 for EQ-5D-5L Quality of Life Assessment Score (5 to 25, lower indicating better quality of life)
Measured: Assessed as a continual variable from Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start31 Oct 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled parallel-arm trial to evaluate the safety and effect of three IV doses of NTS-521 vs placebo for the early recovery treatment of Acute Ischemic Stroke (AIS).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroTrauma Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bijoy A Menon, MD, Principal investigator, The University of Calgary Stroke Program & Stroke Clinical Trial Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742098
- Sponsor's protocol ID
- NTS-521-A015-201
- Acronym
- ACT-IVATE
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Domain Within the ACT-GLOBAL Trial Platform, 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
- ClinicalTrials.gov ID
- NCT07742098
- Acronym / sponsor ID
- ACT-IVATE / NTS-521-A015-201
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, AIS, Ischemic Stroke, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- NeuroTrauma Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke represents a major global public health crisis, characterized by a paradox: declining age-standardized rates yet a rapidly expanding absolute global burden. According to recent epidemiological analyses from the Global Burden of Disease (GBD) study there were 11.9 million incident strokes worldwide in 2021, corresponding to a global age-standardized incidence rate of 141.5 per 100,000 person-years. Stroke claimed 7.3 million lives (an age-standardized mortality rate of 87.4 per 100,000), making it the third leading cause of mortality worldwide, accounting for 10.7% of all deaths.
The trial's target population for NTS-521 intervention consists of participants undergoing endovascular thrombectomy (EVT), and/or intravenous thrombolysis (IVT), or medical care without reperfusion treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled parallel-arm trial to evaluate the safety and effect of three IV doses of NTS-521 vs placebo for the early recovery treatment of Acute Ischemic Stroke (AIS).
| Arm | Type | Receives |
|---|---|---|
| Placebo 0.9% saline solution | Placebo comparator | Other: Placebo Control0.9% saline solution |
| Low Dose NTS-521 | Experimental | Drug: NTS-521Low Dose NTS-521 in 0.9% saline delivered IV |
| Medium Dose NTS-521 | Experimental | Drug: NTS-521Medium Dose NTS-521 in 0.9% saline delivered IV |
| High Dose NTS-521 | Experimental | Drug: NTS-521High Dose NTS-521 in 0.9% saline delivered IV |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTS-521Intravenous NTS-521 | Drug | High Dose NTS-521, Low Dose NTS-521, Medium Dose NTS-521 |
| Placebo Control0.9% saline solution delivered intravenously | Other | Placebo 0.9% saline solution |
Primary outcome
Safety Assessment
Time frame: Safety assessments between baseline and Day 30 and Day 90
Count of incident adverse events by treatment arm, including Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reaction (SUSARs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI - CTCAE v6.0), Vital signs and electrocardiograph (ECG) assessed by descriptive statistics, shift tables, and normal range criteria, and standard biochemical and hematology laboratory panel, assessed by descriptive statistics, shift tables, and normal range criteria
4 secondary outcomes
Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)
Time frame: Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
National Institutes of Health Stroke Scale Assessment (NIHSS)
Time frame: Assessed as a continuous variable from baseline to Day 90
Modified Rankin Score (mRS)
Time frame: Assessed as an ordinal variable from Baseline to Day 90
EuroQual-5D-5L Assessment (EQ-5D-5L)
Time frame: Assessed as a continual variable from Baseline to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bijoy A Menon, MD principal investigator
The University of Calgary Stroke Program & Stroke Clinical Trial Group
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTS-521 in people with Acute Ischemic Stroke, run by NeuroTrauma Sciences, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott C Oshana, BS (18603022074, s.oshana@neurotraumasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: Safety assessments between baseline and Day 30 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.