NoNO-42 for Stroke

Phase 2

Recruiting

Research Sponsored by NoNO Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute ischemic stroke (AIS) selected for thrombolysis with or without EVT.

Ages ≥ 45 to ≤ 90 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days from intervention

Summary

This trial is part of a larger platform called ACT-GLOBAL. It is a Phase 2b study that will involve up to 600 male and female participants between the ages of 45 and

Who is the study for?

This trial is for men and women aged 45 to 90 who've had a stroke recently (within the last 3 hours) and are eligible for clot-busting treatment or a procedure to remove the clot. They should have a moderate-to-severe stroke, be able to live independently before the stroke, and give informed consent.

What is being tested?

The NoNO-42 Trial tests whether a single dose of NoNO-42 can help people recovering from an acute ischemic stroke better than a placebo. Participants will either receive this new drug or a placebo alongside standard treatments like thrombolysis or thrombectomy.

What are the potential side effects?

Specific side effects of NoNO-42 aren't detailed here, but common risks in stroke medication trials include bleeding, allergic reactions, headache, nausea, and potential interactions with other drugs used during standard care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am chosen for clot-dissolving treatment for my stroke.

Select...

I am between 45 and 90 years old.

Select...

I have had a severe stroke with an NIHSS score over 5.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days from intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days from intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days from intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Improving excellent functional outcome

Improving health-related quality of life

Reducing mortality rate

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NoNO-42Active Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Randomized participants will be given a single 20-minute intravenous dose of placebo (comprising normal saline infusion only) with a target start time of less than 10 minutes from randomization.

0 / 3Eligibility criteria met