Recruiting
Phase 2

NoNO-42

Sponsor:

NoNO Inc.

Code:

NCT06403267

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NoNO-42

Study Details

Brief 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.

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.

Conditions

Acute Ischemic Stroke

Study ID

NCT06403267

Start date

Oct 2, 2024

Status verified date

Jul, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Large extent early ischemic changes/infarct in the ischemic territory on qualifying imaging.
2. Any intracranial hemorrhage on qualifying imaging.
3. Unlikely to initiate study drug administration before arterial puncture in those selected for EVT.
4. Known/suspected pregnancy and/or lactation.
5. Systolic blood pressure < 90 mmHg
6. 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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NoNO-42

Randomized 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.

no intervention: Control

Interventions

NoNO-42

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

Primary outcome measure

  • Reducing global disability in participants with acute ischemic stroke (AIS) [ Time Frame: 90 days from intervention ]

Central Contacts and Locations

Central contacts

Michael Tymianski, MD PhD

416-583-1687mtymianski@nonoinc.ca

Locations

University of Calgary - Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Principal Investigator:

Michael Hill, MD

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Principal Investigator:

Brian Buck, MD

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5M 1Z9

Contacts

Principal Investigator:

Thalia Field, MD

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P5

Contacts

Principal Investigator:

Nishita Singh, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Principal Investigator:

Luciana Catanese, MD

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

DARIUSH DOWLATSHAHI, MD

613-798-5555ddowlat@toh.ca

Principal Investigator:

DARIUSH DOWLATSHAHI, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Richard Swartz, MD

Unity Health Toronto, St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Principal Investigator:

Alexandra Muccilli, MD

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Principal Investigator:

Gary Hunter, MD

More Information

Sponsor

NoNO Inc.

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

  • Thrombolysis, Endovascular thrombectomy
  • Reperfusion
  • Neuroprotection
  • Neuroprotectant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NoNO Inc. on 2025-07-15.