Stroke, AcutePhase 3ESCAPE-NEXTNCT04462536
Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
A Phase 3 study testing Nerinetide in people with Stroke, Acute, run by NoNO Inc. at 81 sites in 9 countries.
Trial summary
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Nerinetide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 81 sitesin 9 countries
- Study dates
- 6 Dec 2020to 31 Aug 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
- Age 18 years or greater.
- Onset (last-known-well) time to randomization time within 12 hours.
- Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS):
- NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion; or
- NIHSS > 10 for M2-MCA occlusion.
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- Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) ≥ 95. Patient must be living without requiring nursing care.
- Qualifying imaging performed less than 2 hours prior to randomization.
- Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
Who cannot join
- Treated with a tissue plasminogen activator (e.g., alteplase or tenecteplase) within 24 hours before randomization.
- Determination by the treating physician, based on current treatment guidelines and medical evidence, that treatment with a plasminogen activator is indicated.
- Large core of established infarction defined as ASPECTS 0-4.
- Absent or poor collateral circulation on qualifying imaging (e.g. collateral score of 0 or 1).
- Any intracranial hemorrhage on the qualifying imaging.
- Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
Show all 15Show fewer
- Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure.
- Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
- Estimated or known weight > 120 kg (264 lbs).
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
- Known prior receipt of nerinetide for any reason, including prior enrolment in this ESCAPE-NEXT trial.
- Severe known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
- Severe or fatal comorbid illness that will prevent improvement or follow up.
- Inability to complete follow-up treatment to Day 90.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion.
Trial locations and contacts
81 sites in 9 countries.
81 sites in 9 countries
Germany23 sites
Universitätsklinikum RWTH Aachen
Aachen
Klinikum Altenburger Land GmbH
Altenburg
Universitätsklinikum Augsburg
Augsburg
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum
Universitätsklinikum Bonn
Bonn
Klinikum Dortmund gGmbH
Dortmund
University of Dresden
Dresden
Alfried-Krupp-Krankenhaus
Essen
Universitätsklinikum Frankfurt
Frankfurt
Universitätsklinikum Freiburg
Freiburg im Breisgau
Göttingen University Hospital
Göttingen
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Heidelberg University Hospital
Heidelberg
University Hospital Schleswig-Holstein
Kiel
Universitätsklinikum Leipzig - Klinik und Poliklinik für Neurologie
Leipzig
Klinikum rechts der Isar Technical University of Munich
München
LMU Klinikum München
München
Universitätsklinikum Münster
Münster
Nürnberg Hospital South Campus
Nuremberg
Evangelisches Krankenhaus Oldenburg
Oldenburg
Klinikum Stuttgart
Stuttgart
Universitätsklinikum Tübingen
Tübingen
Würzburg University Hospital
Würzburg
United States17 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Maryland Medical Center
Baltimore, Maryland, 21201
NYU Langone Hospital Brooklyn
Brooklyn, New York, 11220
The Ohio State University, Wexner Medical Center Neurological Surgery
Columbus, Ohio, 43203
Swedish Medical Center
Englewood, Colorado, 80113
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, 78550
Baptist Health Research Institute
Jacksonville, Florida, 32207
University of Miami, Jackson Memorial Hospital
Miami, Florida, 33136
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
UPMC Stroke Institute
Pittsburgh, Pennsylvania, 15213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Rhode Island Hospital
Providence, Rhode Island, 02903-4923
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, 98122
Montefiore Medical Center
The Bronx, New York, 10467
Providence Little Company of Mary Medical Center - Torrance
Torrance, California, 90503
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Canada16 sites
Foothills Medical Centre - University of Calgary
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario
London Health Sciences Centre (LHSC)
London, Ontario
Montreal Neurological Institute and Hospital
Montreal, Quebec
University Hospital of Montreal
Montreal, Quebec
Ottawa Hospital Research Institute (OHRI)
Ottawa, Ontario
CHU de Quebec-Universite Laval
Québec, Quebec
Royal University Hospital
Saskatoon, Saskatchewan
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario
Sunnybrook Health Science Centre
Toronto, Ontario
Toronto Western Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
Health Sciences Centre
Winnipeg, Manitoba
Australia8 sites
Royal Adelaide Hospital
Adelaide
Princess Alexandra Hospital
Brisbane
Monash Medical Centre
Clayton
Gold Coast University Hospital
Gold Coast
Fiona Stanley Hospital
Murdoch
Sir Charles Gairdner Hospital
Nedlands
John Hunter Hospital
Newcastle
Royal Melbourne Hospital
Parkville
Italy5 sites
Ospedale Maggiore di Bologna "Carlo Alberto Pizzardi"
Bologna
Azienda Ospedaliero Universitaria Careggi
Florence
Ospedale Policlinico San Martino
Genoa
ASST Grande Ospedale Metropolitano Niguarda
Milan
Azienda Ospedaliera Antonio Cardarelli
Naples
Norway4 sites
Oslo University Hospital Rikshospitalet
Oslo
Oslo University Hospital Ulleval
Oslo
Stavanger University Hospital
Stavanger
University Hospital of North-Norway
Tromsø
Netherlands3 sites
Amsterdam UMC
Amsterdam
Maastricht University Medical Center
Maastricht
Erasmus University Medical Center
Rotterdam
Switzerland3 sites
Kantonsspital Aarau
Aarau
Universitätsspital Basel
Basel
Universitatsklinik fur Neurologie, Inselspital
Bern
Singapore2 sites
National Neuroscience Institute
Singapore
National University Hospital
Singapore
About this study
Official title: A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).
Read the detailed description
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose with a single interim analysis. Because AIS (acute ischemic stroke) is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments without delay in order to save the life of the person concerned, restore good health or alleviate suffering.
Participants harboring an acute ischemic stroke who are selected for endovascular revascularization without intravenous or intra-arterial thrombolytic therapy will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of nerinetide or placebo. Outcomes of the main trial will be evaluated throughout a 90 day observation period.
Participants will be followed at 1-Year for the analytic sub-trial for further outcome assessment by telemedicine or telephone interview conducted by individuals blinded to the outcome of the main trial. This sub-trial will be conducted to explore the independent functioning and quality of life at 1-Year.
- Conditions
- Stroke, Acute
- Being tested
- Placebo, Nerinetide
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Vehicle only
NerinetideDrug
Also called NA-1
Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Vehicle only Receives: Drug: Placebo |
| Nerinetide | Experimental | Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes Receives: Drug: Nerinetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Measured: 90 days
Secondary outcomes (3)
Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.
The estimand of mortality rate was the adjusted unconditional population difference in the number of deaths observed divided by the number of participants observed over the 90-day study period (mortality proportions) between treatment conditions (nerinetide vs. placebo) in the target patient population at Day 90. Deaths occurring over the Day 90 period were considered as non-responses.
Measured: 90 days
Number of Participants Exhibiting a Worsening of Their Index Stroke.
Worsening of stroke is defined as (A) progression, or hemorrhagic transformation of the index stroke, as documented by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥4 point increase from lowest NIHSS during hospitalization or (B) results in death from the index stroke.
Measured: 90 days
Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start6 Dec 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- NoNO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Michael D. Hill, MD MSc, Principal investigator, Study Principal Investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462536
- Sponsor's protocol ID
- NA-1-009
- Acronym
- ESCAPE-NEXT
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2020
- Last updated
- 22 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hill MD, Goyal M, Demchuk AM, Menon BK, Field TS, Guest WC, Berrouschot J, Bormann A, Pham M, Haeusler KG, Dippel DWJ, van Doormaal PJ, Dorn F, Bode FJ, van Adel BA, Sahlas DJ, Swartz RH, Da Costa L, Ospel JM, McDonough RV, Ryckborst KJ, Almekhlafi MA, Heard KJ, Garman DJ, Adams C, Kohli Y, Schoon BA, Buck BH, Muto M, Zafar A, Schneider H, Grossberg JA, Yeo LLL, Tarpley JW, Psychogios MN, Coutinho JM, Limbucci N, Puetz V, Kelly ME, Campbell BCV, Poli S, Poppe AY, Shankar JJ, Chandra R, Dowlatshahi D, Lopez GA, Cirillo L, Moussaddy A, Devlin M, Garcia-Bermejo P, Mandzia JL, Skjelland M, Aamodt AH, Silver FL, Kleinig TJ, Pero G, Minnerup J, McTaggart RA, Puri AS, Chiu AHY, Reimann G, Gubitz GJ, Camden MC, Lee SK, Sauvageau E, Mundiyanapurath S, Frei DF, Choe H, Rocha M, Gralla J, Bailey P, Fischer S, Liebig T, Dimitriadis K, Gandhi D, Chapot R, Jin A, Hassan AE, Zwam WV, Maier IL, Wiesmann M, Niesen WD, Advani R, Eltoft A, Asdaghi N, Murphy C, Remonda L, Ghia D, Jansen O, Holtmannspoetter M, Hellstern V, Witt K, Fromme A, Nimjee SM, Turkel-Parella D, Michalski D, Maegerlein C, Tham CH, Tymianski M; ESCAPE-NEXT Investigators. Efficacy and safety of nerinetide in acute ischaemic stroke in patients undergoing endovascular thrombectomy without previous thrombolysis (ESCAPE-NEXT): a multicentre, double-blind, randomised controlled trial. Lancet. 2025 Feb 15;405(10478):560-570. doi: 10.1016/S0140-6736(25)00194-1.
PubMed 39955119
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
- ClinicalTrials.gov ID
- NCT04462536
- Acronym / sponsor ID
- ESCAPE-NEXT / NA-1-009
- Conditions
- Stroke, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- NoNO Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Posted 22 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).
Detailed description
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose with a single interim analysis. Because AIS (acute ischemic stroke) is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments without delay in order to save the life of the person concerned, restore good health or alleviate suffering.
Participants harboring an acute ischemic stroke who are selected for endovascular revascularization without intravenous or intra-arterial thrombolytic therapy will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of nerinetide or placebo. Outcomes of the main trial will be evaluated throughout a 90 day observation period.
Participants will be followed at 1-Year for the analytic sub-trial for further outcome assessment by telemedicine or telephone interview conducted by individuals blinded to the outcome of the main trial. This sub-trial will be conducted to explore the independent functioning and quality of life at 1-Year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboVehicle only |
| Nerinetide | Experimental | Drug: NerinetideSingle intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
- Age 18 years or greater.
- Onset (last-known-well) time to randomization time within 12 hours.
- Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS):
- Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
Key exclusion criteria (15 listed)
- Treated with a tissue plasminogen activator (e.g., alteplase or tenecteplase) within 24 hours before randomization.
- Determination by the treating physician, based on current treatment guidelines and medical evidence, that treatment with a plasminogen activator is indicated.
- Large core of established infarction defined as ASPECTS 0-4.
- Absent or poor collateral circulation on qualifying imaging (e.g. collateral score of 0 or 1).
- Any intracranial hemorrhage on the qualifying imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboVehicle only | Drug | Placebo |
| NerinetideAlso: NA-1Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes | Drug | Nerinetide |
Primary outcome
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2
Time frame: 90 days
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
3 secondary outcomes
Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.
Time frame: 90 days
Number of Participants Exhibiting a Worsening of Their Index Stroke.
Time frame: 90 days
Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39955119Hill MD, Goyal M, Demchuk AM, Menon BK, Field TS, Guest WC, Berrouschot J, Bormann A, Pham M, Haeusler KG, Dippel DWJ, van Doormaal PJ, Dorn F, Bode FJ, van Adel BA, Sahlas DJ, Swartz RH, Da Costa L, Ospel JM, McDonough RV, Ryckborst KJ, Almekhlafi MA, Heard KJ, Garman DJ, Adams C, Kohli Y, Schoon BA, Buck BH, Muto M, Zafar A, Schneider H, Grossberg JA, Yeo LLL, Tarpley JW, Psychogios MN, Coutinho JM, Limbucci N, Puetz V, Kelly ME, Campbell BCV, Poli S, Poppe AY, Shankar JJ, Chandra R, Dowlatshahi D, Lopez GA, Cirillo L, Moussaddy A, Devlin M, Garcia-Bermejo P, Mandzia JL, Skjelland M, Aamodt AH, Silver FL, Kleinig TJ, Pero G, Minnerup J, McTaggart RA, Puri AS, Chiu AHY, Reimann G, Gubitz GJ, Camden MC, Lee SK, Sauvageau E, Mundiyanapurath S, Frei DF, Choe H, Rocha M, Gralla J, Bailey P, Fischer S, Liebig T, Dimitriadis K, Gandhi D, Chapot R, Jin A, Hassan AE, Zwam WV, Maier IL, Wiesmann M, Niesen WD, Advani R, Eltoft A, Asdaghi N, Murphy C, Remonda L, Ghia D, Jansen O, Holtmannspoetter M, Hellstern V, Witt K, Fromme A, Nimjee SM, Turkel-Parella D, Michalski D, Maegerlein C, Tham CH, Tymianski M; ESCAPE-NEXT Investigators. Efficacy and safety of nerinetide in acute ischaemic stroke in patients undergoing endovascular thrombectomy without previous thrombolysis (ESCAPE-NEXT): a multicentre, double-blind, randomised controlled trial. Lancet. 2025 Feb 15;405(10478):560-570. doi: 10.1016/S0140-6736(25)00194-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D. Hill, MD MSc principal investigator
Study Principal Investigator, University of Calgary
81 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerinetide in people with Stroke, Acute, run by NoNO Inc. at 81 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Germany, United States, Canada, Australia, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.