Field Randomization of Nerinetide (NA-1) Therapy in Early Responders

(FRONTIER Trial)

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

532 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether nerinetide can reduce disability in stroke patients if given soon after symptoms start. The drug aims to protect brain cells from damage. The study involves paramedics giving the drug to patients in the ambulance before they reach the hospital.

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.

How does the drug NA-1 differ from other treatments for pain management?

NA-1 is unique because it targets the regulation of sodium channels, specifically NaV1.7, by preventing the addition of a small protein called SUMO to another protein, CRMP2. This action reduces the activity and surface expression of NaV1.7, which is crucial in pain signaling, offering a novel non-opioid approach to managing persistent pain. ^{1 2 3 4 5}

Research Team

Jim Christenson, M.D.

Principal Investigator

University of British Columbia

Richard Swartz, M.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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)

Treatment Details

Interventions

• NA-1

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Non-SUMOylated CRMP2 decreases NaV1.7 currents via the endocytic proteins Numb, Nedd4-2 and Eps15. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Regulation of the voltage-dependent sodium channel NaV1.1 by AKT1. [2022]

3. England pubmed.ncbi.nlm.nih.gov

SUMOylation of NaV1.2 channels regulates the velocity of backpropagating action potentials in cortical pyramidal neurons. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cell specific regulation of NaV1.7 activity and trafficking in rat nodose ganglia neurons. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Expression of voltage-gated sodium channel Nav1.5 in non-metastatic colon cancer and its associations with estrogen receptor (ER)-β expression and clinical outcomes. [2018]