Nerinetide for Stroke

(FRONTIER Trial)

No longer recruiting at 3 trial locations

Overseen By Kathy Heard, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NoNO Inc.

Disqualifiers: Seizure, Major head trauma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 10 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called nerinetide (NA-1) to determine if it can reduce disability after a stroke. The goal is to assess whether administering this medication soon after stroke symptoms begin can improve recovery. Participants will receive either nerinetide or a placebo (a substance with no active drug) through an IV for 10 minutes. The trial seeks individuals who recently had a stroke and could walk independently before it occurred. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that nerinetide (NA-1) is likely to be safe for humans?

Research has shown that nerinetide (NA-1) is generally safe for humans. In earlier studies, participants who took nerinetide experienced significant benefits without major safety issues. These studies examined factors such as death rates and brain health, finding that nerinetide did not increase the risk of negative effects. This treatment has been tested at doses similar to those in this trial, aiming to reduce disability from strokes when administered soon after symptoms begin. Evidence suggests that nerinetide is safe, with no reports of serious side effects directly linked to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for stroke, which often focus on dissolving clots or preventing further strokes, Nerinetide (NA-1) works by protecting brain cells from damage after a stroke. This neuroprotective agent acts by inhibiting a key protein involved in cell death, which could potentially minimize brain injury during the critical early hours after a stroke. Researchers are particularly excited about Nerinetide because it offers a novel approach to stroke treatment, aiming to preserve brain function and improve recovery outcomes.

What evidence suggests that NA-1 might be an effective treatment for acute cerebral ischemia?

In this trial, participants will receive either nerinetide (NA-1) or a placebo. Research has shown that nerinetide can help reduce disability after a stroke. Specifically, studies found that patients who received nerinetide had better scores on a disability scale. Another study found that nerinetide slowed the growth of the damaged brain area in animals. While not all patients saw improvements, those who did not use alteplase (a clot-busting drug) experienced better results. Overall, early treatment with nerinetide appears promising for improving recovery after a stroke. ^{1 2 5 6 7}

Who Is on the Research Team?

Jim Christenson, M.D.

Principal Investigator

University of British Columbia

Richard Swartz, M.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

Inclusion Criteria

You have experienced symptoms of LAMS (lung volume reduction coil (LVRC) treatment assessment) for at least 15 minutes and your score remains between 2 and 5 at the time of enrollment.

Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool

Oxygen saturation ≥ 90% on room air

Exclusion Criteria

You had a seizure when your symptoms started or when the paramedic was present.

You had a serious injury to your head within the past three months.

You have had a stroke within the past three months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Immediate

Field screening by paramedics

Treatment

Participants receive a single 10 minute IV infusion of nerinetide or placebo administered by paramedics in the field

10 minutes

1 visit (in-field)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including the Modified Rankin Scale, NIHSS, and Barthel Index

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• NA-1

How Is the Trial Designed?

Group I: Nerinetide (NA-1) Experimental Treatment 1 Intervention

2.60 mg/kg of nerinetide (up to a maximum dose of 270 mg) administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.

Group II: Placebo Placebo Group 1 Intervention

Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.

Who Is Running the Clinical Trial?

NoNO Inc.

Lead Sponsor

Trials

7

Recruited

3,400+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Djavad Mowafaghian Centre for Brain Health

Collaborator

Trials

2

Recruited

610+

Canadian Stroke Network

Collaborator

Trials

10

Recruited

3,700+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Genome British Columbia

Industry Sponsor

Trials

13

Recruited

223,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39956129/

Safety and efficacy of nerinetide in patients with acute ... Nerinetide showed a clinically significant benefit over several outcome measures, including the modified Rankin Scale score, the incidence of stroke worsening, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442224005155

Safety and efficacy of nerinetide in patients with acute ... Nerinetide showed a clinically significant benefit over several outcome measures, including the modified Rankin Scale score, the incidence of stroke worsening, ...

3. ahajournals.org ahajournals.org/doi/10.1161/SVIN.123.001034

Nerinetide Reduces Early Infarct Growth Among Stroke ... In preclinical studies in rats and primates, treatment with nerinetide not only reduced infarct volumes but also slowed infarct growth. We used ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39955119/

Efficacy and safety of nerinetide in acute ischaemic stroke ... While nerinetide did not improve outcomes in patients with acute ischaemic stroke, it was not associated with excess adverse events.

5. j-stroke.org j-stroke.org/journal/view.php?number=564

Factors Influencing Nerinetide Effect on Clinical Outcome ... Patients in the nerinetide arm who were not treated with concurrent alteplase showed improved clinical outcomes and the treatment effect was larger among ...

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00194-1/abstract

Efficacy and safety of nerinetide in acute ischaemic stroke ... Secondary outcomes were measures of mortality, worsening of stroke, improved functional independence, and measures of neurological disability.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02930018

NCT02930018 | Safety and Efficacy of Nerinetide (NA-1) in ... Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg (up to a maximum dose of 270 mg) ...