Field Randomization of NA-1 Therapy in Early Responders (FRONTIER)
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| ClinicalTrials.gov Identifier: NCT02315443 |
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Recruitment Status :
Recruiting
First Posted : December 11, 2014
Last Update Posted : December 22, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Cerebral Ischemia | Drug: NA-1 Drug: Placebo | Phase 3 |
NA-1 is being developed as an emergency drug aimed at reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.
The primary objective is to determine the efficacy of NA-1 in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of NA-1 in reducing functional dependence, improving neurological outcome, improving activities of daily living, and increasing the proportion of subjects who are candidates for endovascular recanalization therapy.
The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of NA-1 within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality.
This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study initiated prehospital in the ambulance. It is being conducted using Emergency Medical Services (EMS) in Canada. Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system, and further screened for eligibility and approval by an on-call trial physician. The paramedics will administer the study drug. Upon arrival at the emergency department, subjects will receive standard-of-care.
An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 558 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset |
| Actual Study Start Date : | March 26, 2015 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | May 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NA-1
2.60 mg/kg of NA-1 (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.
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Drug: NA-1 |
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Placebo Comparator: Placebo
Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
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Drug: Placebo |
- Modified Rankin Scale (mRS) scale [ Time Frame: 90 days ]The percentage of responders, using a sliding dichotomy on the mRS
- Key secondary endpoint: Modified Rankin Scale (mRS) scale [ Time Frame: 90 days ]The primary endpoint analysis (i.e. percentage of responders, using a sliding dichotomy on the mRS scale at Day 90) performed in the confirmed acute cerebral ischemia subset of subjects.
- mRS shift analysis [ Time Frame: 90 Days or the last rating ]Shift to reduced functional dependence analyzed across the whole distribution of scores on the mRS
- Proportion of subjects with functional independence [ Time Frame: 90 Days or the last rating ]
Proportion of subjects with functional independence, as defined by a score of a) 0-2 and b) 0-
1 on the mRS
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 90 Days or the last rating ]Proportion of subjects with good neurological outcome, as defined by a score of 0-1 on the NIHSS
- Barthel Index [ Time Frame: 90 Days or the last rating ]Proportion of subjects with functional independence in activities of daily living, as defined by a score of ≥ 95 on the Barthel Index
- Eligibility for endovascular recanalization [ Time Frame: 24 hours ]Proportion of subjects who are deemed to be candidates for endovascular recanalization therapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 95 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool
- Respiratory rate 12-24 breaths per minute
- Oxygen saturation ≥ 90% on room air
- Systolic blood pressure < 90 or > 220 mmHg
- Weight 45-120 kg
- Last seen in usual state of health less than 3 hours before anticipated study drug initiation
- Independently ambulatory with or without devices prior to event
- LAMS score of 2-5 for at least 15 minutes and remains 2-5 at time of randomization
Exclusion Criteria:
- Lack of IV access
- Canadian Triage and Acuity Scale Level 1 and/or uncorrected airway, breathing or significant circulatory problem
- Blood sugar < 3 mmol/L (< 55 mg/dL)
- Seizure at onset of symptoms or observed by paramedic
- Glasgow coma score of <10
- Major head trauma in the last three months
- Recent stroke in the last three months with or without residual deficit
- Known or presumptive signs of pregnancy or breastfeeding
- Prisoner
- Long term care facility resident
- Known advance directive to not resuscitate
- Valid Emergency Health Services Do Not Resuscitate Consent Form
- Known participation in a clinical trial with an investigational drug or device within 30 days preceding this trial
- Pre-existing neurologic, psychiatric, or advanced systemic condition that would preclude obtaining the neurological or functional outcome evaluations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315443
| Contact: Michael Tymaisnki, M.D. | (416) 603-5899 | mtymianski@nonoinc.ca | |
| Contact: Kathy Heard, M.Sc. | (416) 603-5899 | kheard@nonoinc.ca |
| Canada, British Columbia | |
| Kelowna General Hospital | Recruiting |
| Kelowna, British Columbia, Canada, V1Y 1T2 | |
| Contact: Aleksander Tkach, MD | |
| Royal Columbian Hospital | Recruiting |
| New Westminster, British Columbia, Canada, V3L 3W7 | |
| Contact: George Medvedev, MD | |
| British Columbia Ambulance Service and British Columbia Emergency Health Services | Recruiting |
| Vancouver, British Columbia, Canada, V5M 4X6 | |
| Contact: Sandra Jenneson, M.D. | |
| Vancouver General Hospital, Vancouver Coastal Health | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Oscar Benavente, MD | |
| Principal Investigator: | Jim Christenson, M.D. | University of British Columbia | |
| Principal Investigator: | Richard Swartz, M.D. | Sunnybrook Health Sciences Centre |
| Responsible Party: | NoNO Inc. |
| ClinicalTrials.gov Identifier: | NCT02315443 |
| Other Study ID Numbers: |
NA-1-005 HC6-24-c 195121 ( Other Identifier: Health Canada ) |
| First Posted: | December 11, 2014 Key Record Dates |
| Last Update Posted: | December 22, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Stroke Ischemia Prehospital NA-1 |
Modified Rankin Scale Haemorrhagic stroke Transient ischemic attack |
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Brain Ischemia Cerebral Infarction Ischemia Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Stroke |