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Acute Ischemic StrokePhase 2NCT06403267

NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy

A Phase 2 study testing NoNO-42 in people with Acute Ischemic Stroke, run by NoNO Inc. at 9 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

ACT-42 is a domain of the ACT-GLOBAL platform (NCT06352632). This trial is a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
NoNO-42
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
9 sitesCanada
Study dates
2 Oct 2024to Dec 2026
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed or suspected acute ischemic stroke (AIS) selected for intravenous thrombolysis.
  • Onset (last-known-well) time to randomization time within 4.5 hours.
  • Ages ≥ 18 to ≤ 90 years.
  • Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) >5.
  • Confirmed or suspected symptomatic anterior circulation intracranial occlusion. Tandem extracranial carotid and intracranial occlusions are permitted.
  • Pre-stroke independent functional status in activities of daily living as judged by the enrolling physician. Patient must be living without requiring nursing care.
  • Consent process completed as per national laws and regulation and the applicable ethics committee requirements.

Who cannot join

  • Large extent early ischemic changes/infarct in the ischemic territory on qualifying imaging.
  • Any intracranial hemorrhage on qualifying imaging.
  • Unlikely to initiate study drug administration before arterial puncture in those selected for EVT.
  • Known/suspected pregnancy and/or lactation.
  • Systolic blood pressure < 90 mmHg
  • Known prior receipt of NoNO-42 for any reason, including prior enrolment in this trial.
  • 8) Severe comorbid illness with life expectancy less than 90 days, or likely to prevent completing 90-day follow-up.
  • 9) Long term care facility resident or prisoner 10) Participation in another clinical trial outside of the ACT-GLOBAL platform investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding trial enrolment.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Tymianski, MD PhD contact

416-583-1687

mtymianski@nonoinc.ca

9 sites in 1 country

Canada9 sites, 9 recruiting

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

    Michael Hill, MD, 403-210-7786, michael.hill@ucalgary.ca

    Michael Hill, MD

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Brian Buck, MD, 780-248-1927, bbuck@ualberta.ca

    Brian Buck, MD

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Luciana Catanese, MD, 905-902-9142, luciana.catanese@phri.ca

    Luciana Catanese, MD

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    DARIUSH DOWLATSHAHI, MD, 613-798-5555, ddowlat@toh.ca

    DARIUSH DOWLATSHAHI, MD

    Recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

    Gary Hunter, MD, 306-881-9701, grwhunter@gmail.com

    Gary Hunter, MD

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Richard Swartz, MD, 416-480-4866, rick.swartz@sunnybrook.ca

    Richard Swartz, MD

    Recruiting

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Alexandra Muccilli, MD, 416-864-5377, Alexandra.muccilli@unityhealth.to

    Alexandra Muccilli, MD

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5M 1Z9

    Thalia Field, MD, 604 875-4554, thalia.field@ubc.ca

    Thalia Field, MD

    Recruiting

  • University of Manitoba

    Winnipeg, Manitoba, R3E 3P5

    Nishita Singh, MD, 204-789-3725, nishita.singh@umanitoba.ca

    Nishita Singh, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Multicentre, Prospective, Randomized, Open Label, Blinded-Endpoint, Placebo-controlled, Single-dose Trial to Determine the Efficacy and Safety of NoNO-42 in Participants With Acute Ischemic Stroke Selected for Thrombolysis With or Without Endovascular Thrombectomy (ACT-42 Trial)

ACT-42 is a domain of the ACT-GLOBAL platform (NCT06352632).

This trial is a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial.

A total of up to 600 male and female participants aged ≥ 18 to ≤ 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 4.5 hours of stroke onset/last known well.

Read the detailed description

Because AIS is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments in order to save the life of the person concerned, restore good health and alleviate suffering.

A total of up to 600 male and female participants aged ≥ 18 to ≤ 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 4.5 hours of stroke onset/last known well. Randomization will be 1:1 drug/placebo. Randomization will be stratified by large vessel occlusion (LVO) (yes/no) and a minimization algorithm to minimize the contribution of imbalances in baseline factors (age, sex, baseline NIHSS score). The design is adaptive with prospective rules for adaptive enrichment, in which enrollment may be restricted to participants without an LVO. LVO is defined as an occlusion of the intracranial ICA, M1 or proximal M2.

Randomized participants will receive/received an intravenous thrombolytic and be allocated to:

  • the investigational group, a single, 2.6 mg/kg (up to a maximum of 300 mg) 20-minute intravenous dose of NoNO-42, with a target start time of less than 10 minutes from randomization or
  • the control group, no trial specific intervention.

Day 90: All participants will be followed for 90 days (or until death if prior to 90 days) for efficacy and 30 days for safety. The end of the trial is defined as the date that all participants have completed their Day 90 contact.

1-Year follow Up: participants who completed the trial to Day 90 may be followed at 1 year for long-term efficacy.

One database lock and corresponding report for the trial to Day 90 and a separate database lock and analysis for the 1-year follow up are planned.

Being tested
NoNO-42
Keywords
Thrombolysis, Endovascular thrombectomy, Reperfusion, Neuroprotection, Neuroprotectant
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NoNO-42Drug

    a single dose sterile 20 ml vial containing lyophilized powder for reconstitution containing 300 mg of NoNO-42 active ingredient.

Study groups in NCT06403267
Study groupRoleWhat they receive
NoNO-42Active comparatorRandomized participants will be given a single, 2.6 mg/kg 20-minute intravenous dose of NoNO-42 with a target start time of less than 10 minutes from randomization.
Receives: Drug: NoNO-42
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reducing global disability in participants with acute ischemic stroke (AIS)

    The primary outcome is the mRS at Day 90. The primary analysis of the primary outcome will be a "shift" analysis, which is an ordinal analysis across the mRS scale. The primary estimand is odds-ratio for a better outcome on the mRS scale for NoNO-42 compared to control.

    Measured: 90 days from intervention

Secondary outcomes (5)

  1. Improving excellent functional outcome

    Proportion of participants with a mRS of 0-1 at Day 90

    Measured: 90 days from intervention

  2. Reducing worsening of stroke

    Proportion of participants exhibiting a worsening of their index stroke during hospitalization.

    Worsening of stroke is defined as (A) progression of the index stroke or symptomatic intracranial, or symptomatic intracranial hemorrhagic within the first 7-days after randomization, supported and confirmed by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥ 4-point increase from lowest NIHSS during initial hospitalization or (B) results in death from the index stroke (i.e., index stroke is judged to be the principal cause of death) within the first 21-days after randomization.

    Measured: 90 days from intervention

  3. Improving functional independence

    Proportion of participants with a mRS of 0-2 at Day 90.

    Measured: 90 days from intervention

  4. Reducing mortality rate

    Proportion of participant mortality over the 90-day trial period

    Measured: 90 days from intervention

  5. Improving health-related quality of life

    Health-related quality of life, as measured by the EQ-5D-5L at Day 90

    Measured: 90 days from intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start2 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06403267
Sponsor's protocol ID
NoNO42-02 (ACT-42)
Status last verified
Jul 2025
First submitted
26 Apr 2024
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NoNO-42 in people with Acute Ischemic Stroke, run by NoNO Inc. at 9 sites in Canada.

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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Michael Tymianski, MD PhD (416-583-1687, mtymianski@nonoinc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reducing global disability in participants with acute ischemic stroke (AIS) (time frame: 90 days from intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06403267.

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 15 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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