NCT05065216ClinicalTrials.gov

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

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En resumen

Fase 2 / Fase 3728 participantes buscados86 centros10 países

Categorías

Cardiovascular71%Neurología29%

Registrado en 1 registro

ClinicalTrials.govNCT05065216Abrir este registro en ClinicalTrials.govSincronizado hace 5 días

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-10-04; recorded start 2021-11-07
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (DiaMedica Therapeutics Inc)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type7/10
Clinical-event endpoint
Multi-centre8/8
Multi-centre: 66 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 728 participants (target), run at 86 sites, across 10 countries.

How this score is built

Enrolment28/40
728 participants (target)
Site count21/25
66 sites
Country count12/15
9 countries
Planned duration10/10
Planned over about 62 months
Sponsor scale1/10
DiaMedica Therapeutics Inc has led 3 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.

This is a Phase 2/3 Adaptive Design, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial). Participants with AIS will be randomized 1:1 to DM199 or placebo. DM199 will be administered as a single intravenous (IV) dose (0.5 μg/kg; not to exceed 50 μg) followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. The duration of each individual's participation in the study will be approximately 90 days from the time of initial treatment to completion of all study activities. A formal interim analysis will be conducted after 200 participants complete their Day 90 assessment in Part A. The purposes of this interim analysis are to assess safety, allow early stopping of the study for futility, or continuing the study with a revised final sample up to a maximum of 728 participants.

Afecciones

Acute Stroke
Ischemic Stroke
Stroke

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – 90 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Participant is between 18 and 90 years of age inclusive. 2. Participant weight is 40 kg to 166 kg inclusive. 3. Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset. 4. Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to participants who meet the following conditions: * The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and * Participant meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic transformation. 5. Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative. 6. If participant has received fibrinolytic treatment for AIS within 4.5 hours of last know normal/AIS stoke onset and at least 6 hours after completing fibrinolytic treatment, and the participant meets all of the following criteria: * Participant's initial NIHSS score prior to fibrinolytics was ≤15; and * At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and * The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and * Participant meets all other inclusion and exclusion criteria including repeat brain imaging to rule out hemorrhagic transformation. 7. Participant and/or legally authorized representative is able to provide informed consent. 8. Participant is willing and able to comply with the study protocol, in the Investigator's judgment. Exclusion Criteria: 1. At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke. 2. Participant has image findings with symptomatic large vessel occlusion at one or more of the following locations: Intracranial carotid I/T/L or M1 segment MCA, vertebral or basilar artery (BA). 3. Participant has large core of established infarction defined as ASPECTS 0-5. 4. Participant has or will receive MT for their current AIS. 5. Participant has suspected or confirmed extracranial arterial dissection. 6. Participant has imaging findings and/or symptoms consistent with a brain stem or cerebellar stroke. Posterior cerebral artery strokes without any associated brain stem or cerebellar involvement are allowable. 7. Participant has any recorded SBP \<100 mmHg or MAP \<65 mmHg; MAP = DBP + \[1/3 (SBP - DBP)\] (measured with noninvasive BP cuff type monitor) after stroke symptom onset and prior to randomization. 8. Participant is currently prescribed angiotensin-converting enzyme inhibitor (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 29 ±1 day (8 days after last treatment). 9. Participant is currently prescribed an ACEi, and the last dose of the ACE inhibitor medication is reported to have been taken \< 24 hours before start of IV study drug infusion as stated by participant or participant's representative. 10. Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization. 11. Participant has a diagnosis or suspected diagnosis of hereditary angioedema (HAE) or is taking or prescribed medications commonly used as prophylaxis/treatment of HAE, such as C1-esterase inhibitors (Cinryze, Berinert, Ruconest, Haegarda), Danazol, kallikrein inhibitors (Ecallantide, Berotralstat, Lanadelumab), Bradykinin B2 Receptor Antagonists (Icatibant), or other medication designed to influence the kallikrein-kinin system. 12. Life expectancy estimated at ≤1 year prior to enrollment. 13. Participant has clinical evidence of an active infection at the time of enrollment requiring parenteral treatment or hospitalization to monitor or manage the infection. NOTE: Treatment of uncomplicated infections with oral antibiotics would not be an exclusion (for example, the treatment of uncomplicated urinary tract infections or sinus infections with oral antibiotics would not be exclusionary). 14. Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency). 15. Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator. 16. Participants of child-bearing potential must agree to use medically acceptable contraceptive measures to prevent pregnancy. All participants of childbearing potential (defined as sexually mature participants who have had menses within the preceding 24 months and have not undergone permanent sterilization methods such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) must have a negative serum pregnancy test performed locally at screening. Participants of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, participants must use 2 reliable methods (1 per partner is acceptable) of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period. Participants participating in sexual activity must agree to use, or for their partner to use highly effective birth control methods (those with a failure rate of less than 1% per year when used consistently and correctly) until they have completed the study (after the Day 90 visit). Such methods include: * Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation * Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * Sexual abstinence Participants who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) are not required to use contraception. Participants are prohibited from sperm donation. NOTE: A negative serum pregnancy test will be documented during screening if a participant is of child-bearing potential. 17. Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening. 18. Participant does not have sufficient venous access for infusion of study treatment or blood sampling. 19. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits. 20. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2 / Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	DOUBLE (2)
Inscripción	728 participantes buscados

Patrocinador y colaboradores

DiaMedica Therapeutics Inc Patrocinador

Grupos e intervenciones

DM199EXPERIMENTAL
DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.
Placebo for DM199 Solution for InjectionPLACEBO_COMPARATOR
Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.

Intervenciones

Otro Placebo for DM199 Solution for Injection
Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.
Fármaco Recombinant human tissue kallikrein
DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21

Variables de resultado

Variable de resultado principal
Stroke Recovery
Stroke recovery as defined by participants with excellent functional outcomes at Day 90 as assessed via the Modified Rankin Score (mRS \[dichotomized\]), mRS scores of 0 or 1 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).
Plazo Day 90
Variable de resultado secundaria
Effect on Disability
Assessment of effect on disability across the full spectrum of AIS by examining the distribution of mRS (shift) scores (scale range = 0 to 6) at Day 90. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).
Plazo Day 90
Variable de resultado secundaria
Independent Function
Proportion of participants achieving independent function (able to look after their own affairs without assistance) with or without minor disability at Day 90 assessed as mRS 0-2 (dichotomized) mRS scores of 0, 1 or 2 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).
Plazo Day 90
Variable de resultado secundaria
Mortality Rate
Mortality rate as defined by event rate (%) for mortality over 90 days.
Plazo Day 90
Variable de resultado secundaria
Neurological Outcome
Proportion of participants achieving an excellent neurological outcome defined by National Institute of Health Stroke Scale (NIHSS)= 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90. The National Institute of Health Stroke Scale (NIHSS) is a clinician-reported measure used to rate the severity of strokes, namely disability and recovery after acute stroke. The scale is comprised of 11 items with item scores ranging from 0 to 4. Total scores range from 0 to 42, with higher scores indicating increased severity.
Plazo Day 90
Variable de resultado secundaria
Functional Independence
Proportion of participants achieving an excellent functional independence in activities of daily living defined by Barthel Index score (dichotomized) greater than or equal to 5 (scale range 0 to 100) at Day 90. The Barthel Index (BI) is a 10-item scale assessing activities of daily living and functional disability. Each item is scored in increments of 5 points (0, 5, 10, or 15) and the individual items are summed to produce a total score between 0 and 100, with higher scores representing more optimal performance (100 = fully independent) and lower scores representing inferior performance (0 = totally dependent).
Plazo Day 90
Variable de resultado secundaria
AIS Recurrence
Recurrent AIS as defined by proportion of participants who experience a recurrent AIS by Day 90 as assessed by a new, persistent neurological deficit attributable to cerebrovascular ischemia. Imaging findings, if available, should support the diagnosis.
Plazo Day 90

Fechas

Fechas
Fecha de inicio	7 de noviembre de 2021 (real)
Finalización principal	1 de diciembre de 2026 (estimada)
Finalización	1 de diciembre de 2026 (estimada)
Primera publicación	4 de octubre de 2021 (real)
Última actualización	14 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

78 centros están en reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado o región	Estado
Imeldaziekenhuis (Imelda Hospital)	Bonheiden	Belgium	En reclutamiento
UZ Gent	Ghent	Belgium	En reclutamiento
Jessa Ziekenhuis	Hasselt	Belgium	En reclutamiento
AZ Groeninge	Kortrijk	Belgium	En reclutamiento
CHC Montléga	Liège		En reclutamiento
Clinique St Pierre	Ottignies	Belgium	En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
University of Alberta Hospital	Edmonton	Alberta	En reclutamiento
Hamilton Health Sciences - Hamilton General Hospital	Hamilton	Ontario	En reclutamiento
Health Sciences North	Hamilton	Ontario	En reclutamiento
Sunnybrook Research Institute	North York	Ontario	En reclutamiento
Vancouver General Hospital	Vancouver	British Columbia	En reclutamiento

France

France
Centro	Ciudad	Estado o región	Estado
Hopital Pellegrin CHU Bordeaux	Bordeaux		En reclutamiento
Aphm Hopital Timone	Marseille		En reclutamiento
Chru Nancy Hopital Central	Nancy		En reclutamiento
CHU Pontchaillou /Hopital Sud Service de Neurologie	Rennes	Brittany Region	En reclutamiento
CHU Strasbourg Hopital de Hautepierre	Strasbourg		En reclutamiento

Georgia

Georgia
Centro	Ciudad	Estado o región	Estado
West Georgia Medical Center LTD	Kutaisi	Georgia	Activo, sin reclutar
Israel-Georgia Medical Research Clinic-Healthycore LTD	Tbilisi	Georgia	Activo, sin reclutar
New Hospitals LTD	Tbilisi	Georgia	Activo, sin reclutar
Pineo Medical Ecosystem LTD	Tbilisi	Georgia	Activo, sin reclutar
JSC K. Eristavi National Center of Experimental and Clinical Surgery	Tbilisi	Georgia	Activo, sin reclutar

Hungary

Hungary
Centro	Ciudad	Estado o región	Estado
Bajcsy-Zsilinszky Hospital	Budapest	Hungary	En reclutamiento
North Buda St. John Central Hospital	Budapest		Aún no recluta
Petz Aladár County Teaching Hospital	Győr	Vasvári Pál U. 2-4	En reclutamiento
St. Damjan Greek Catholic Hospital	Kisvárda	Hungary	En reclutamiento
B.-A.-Z. County Central Hospital	Miskolc	Hungary	En reclutamiento

Poland

Poland
Centro	Ciudad	Estado
UCM, Katowice	Katowice	En reclutamiento
University Hospital in Krakow	Krakow	En reclutamiento
Szpital Czerniakowski Warsaw	Warsaw	En reclutamiento
Military Institute of Medicine - National Research Institute	Warsaw	En reclutamiento
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu	Wroclaw	En reclutamiento
University Hospital of Zielona Góra	Zielona Góra	En reclutamiento

Romania

Romania
Centro	Ciudad	Estado o región	Estado
Fundeni Clinical Institute	Bucharest	Bucharest (Sector 2)	En reclutamiento
Elias Emergency University Hospital	Bucharest	Romania	En reclutamiento

Spain

Spain
Centro	Ciudad	Estado o región	Estado
Instituto de Investigacion Biomedica de A Coruna (INIBIC)	A Coruña	Spain	En reclutamiento
Hospital Universitario Germans Trias i Pujol	Badalona	Spain	En reclutamiento
Hospital Universitari Vall d'Hebron-Institut de Recerca	Barcelona	Spain	En reclutamiento
Hospital Clínico Universitario de Santiago	Santiago de Compostela	Spain	En reclutamiento

United Kingdom

United Kingdom
Centro	Ciudad	Estado o región	Estado
Addenbrooke's Hospital	Cambridge	United Kingdom	En reclutamiento
Royal Devon and Exeter Hospital	Exeter	Devon	En reclutamiento
Victoria Hospital- NHS Fife- Scotland- UK	Kirkcaldy		En reclutamiento
Leeds Teaching Hospitals NHS Trust	Leeds		Aún no recluta
St George's Hospital	London	United Kingdom	En reclutamiento
Barts Health NHS Trust The Royal London Hospital	London		En reclutamiento
Charing Cross Hospital	London		En reclutamiento
University College of London	London		En reclutamiento
James Cook University Hospital	Middlesbrough		Aún no recluta
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)	Newcastle upon Tyne	England	En reclutamiento
Nottingham University Hospital	Nottingham		En reclutamiento
Royal Stoke University Hospital	Stoke-on-Trent	United Kingdom	En reclutamiento

En el registro figuran 36 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

21 de agosto de 2026
Centro añadido
20 sites added (86 total)
6686

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05065216