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A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke (ACT-IVATE)

31. juli 2026 opdateret af: NeuroTrauma Sciences, LLC

A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Domain Within the ACT-GLOBAL Trial Platform, to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke

This is a trial to evaluate the safety and effect of three intravenous (IV) doses of NTS-521 for the early recovery treatment of acute ischemic stroke (AIS). Participants will be followed for 90 days.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Stroke represents a major global public health crisis, characterized by a paradox: declining age-standardized rates yet a rapidly expanding absolute global burden. According to recent epidemiological analyses from the Global Burden of Disease (GBD) study there were 11.9 million incident strokes worldwide in 2021, corresponding to a global age-standardized incidence rate of 141.5 per 100,000 person-years. Stroke claimed 7.3 million lives (an age-standardized mortality rate of 87.4 per 100,000), making it the third leading cause of mortality worldwide, accounting for 10.7% of all deaths.

The trial's target population for NTS-521 intervention consists of participants undergoing endovascular thrombectomy (EVT), and/or intravenous thrombolysis (IVT), or medical care without reperfusion treatment.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Acute ischemic stroke with moderate to severe hemiparesis
  • Functional independence in activities of daily living without requiring nursing care before the index stroke.
  • Consent process by participant or proxy, with reconsent provision.
  • Age ≥ 45 to ≤ 80 years of age (inclusive) on the date of randomization
  • Sufficient attention, comprehension, and cooperation to carry out instructions

Exclusion Criteria:

  • Pre-existing motor deficit prior to index stroke
  • Posterior circulation ischemic stroke
  • Lacunar stroke
  • Qualifying brain imaging demonstrating intracranial hemorrhage, malignant middle cerebral artery (MCA) infarct with edema, or bilateral/multifocal infarcts, clinically significant vascular malformation, brain tumor, or other central nervous system (CNS) pathology
  • Recent major surgery or trauma (<30 days)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo 0.9% saline solution
0.9% saline solution
Andet: Placebo Control
0.9% saline solution delivered intravenously
Eksperimentel: Low Dose NTS-521
Low Dose NTS-521 in 0.9% saline delivered IV
Medicin: NTS-521
Intravenous NTS-521
Eksperimentel: Medium Dose NTS-521
Medium Dose NTS-521 in 0.9% saline delivered IV
Medicin: NTS-521
Intravenous NTS-521
Eksperimentel: High Dose NTS-521
High Dose NTS-521 in 0.9% saline delivered IV
Medicin: NTS-521
Intravenous NTS-521

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Assessment
Tidsramme: Safety assessments between baseline and Day 30 and Day 90
Count of incident adverse events by treatment arm, including Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reaction (SUSARs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI - CTCAE v6.0), Vital signs and electrocardiograph (ECG) assessed by descriptive statistics, shift tables, and normal range criteria, and standard biochemical and hematology laboratory panel, assessed by descriptive statistics, shift tables, and normal range criteria
Safety assessments between baseline and Day 30 and Day 90

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)
Tidsramme: Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
Change from baseline to Day 90 in the FMA-UE motor score (0-66; higher is better)
Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
National Institutes of Health Stroke Scale Assessment (NIHSS)
Tidsramme: Assessed as a continuous variable from baseline to Day 90
National Institutes of Health Stroke Scale (0-42; higher is worse)
Assessed as a continuous variable from baseline to Day 90
Modified Rankin Score (mRS)
Tidsramme: Assessed as an ordinal variable from Baseline to Day 90
Modified Rankin Score (mRS) (0-6; higher is worse), assessed as an ordinal variable
Assessed as an ordinal variable from Baseline to Day 90
EuroQual-5D-5L Assessment (EQ-5D-5L)
Tidsramme: Assessed as a continual variable from Baseline to Day 90
Change from baseline to Day 90 for EQ-5D-5L Quality of Life Assessment Score (5 to 25, lower indicating better quality of life)
Assessed as a continual variable from Baseline to Day 90

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NeuroTrauma Sciences, LLC

Efterforskere

  • Ledende efterforsker: Bijoy A Menon, MD, The University of Calgary Stroke Program & Stroke Clinical Trial Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. oktober 2026

Primær færdiggørelse (Anslået)

15. december 2028

Studieafslutning (Anslået)

15. december 2028

Datoer for studieregistrering

Først indsendt

27. juli 2026

Først indsendt, der opfyldte QC-kriterier

31. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NTS-521-A015-201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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