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

NCT06403267 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NoNO42-02 (ACT-42)
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 9

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

Keywords

Thrombolysis, Endovascular thrombectomy; Reperfusion; Neuroprotection; Neuroprotectant

Outcome Measures

Primary Outcomes (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.

  90 days from intervention

Secondary Outcomes (5)

• Improving excellent functional outcome

  90 days from intervention

• Reducing worsening of stroke

  90 days from intervention

• Improving functional independence

  90 days from intervention

• Reducing mortality rate

  90 days from intervention

• Improving health-related quality of life

  90 days from intervention

Other Outcomes (2)

• 1 year Follow-up

  1 year post intervention

• Safety Outcome

  30 and 90 days post intervention

Study Arms (2)

NoNO-42

ACTIVE COMPARATOR

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.

Drug: NoNO-42

Control

NO INTERVENTION

Interventions

NoNO-42 DRUG

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

NoNO-42

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \) Severe comorbid illness with life expectancy less than 90 days, or likely to prevent completing 90-day follow-up.
• \) 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.

Sponsors & Collaborators

• NoNO Inc.: lead
• University of Calgary: collaborator

Study Sites (9)

University of Calgary - Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5M 1Z9, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3E 3P5, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bijoy Menon, MBBS, MD

  University of Calgary

  STUDY CHAIR

Central Study Contacts

Michael Tymianski, MD PhD

CONTACT

416-583-1687; mtymianski@nonoinc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Potential bias will be reduced by the following steps: * allocation concealment: via online central randomization * trial participants will remain blinded to dose and treatment allocation and will not be informed until after database lock. * blinded endpoint assessment, at Days 30 and 90 central blinded assessors will contact the participants for mRS and EQ-5D-5L assessments. Clinical site staff, including the Principal Investigator (PI), sub-investigators, clinic site staff, and the Sponsor will not be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)