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Not yet recruiting NCT07742098

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

Phase II Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NTS-521, Placebo Control.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug NTS-521
    Intravenous NTS-521
  • Other Placebo Control
    0.9% saline solution delivered intravenously

Primary outcome measures

  • Safety Assessment [Time frame: Safety assessments between baseline and Day 30 and Day 90]
Secondary outcome measures (4)
  • Fugl-Meyer- Upper Extremity Motor Score (FMA-UE) [Time frame: 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) [Time frame: Assessed as a continuous variable from baseline to Day 90]
  • Modified Rankin Score (mRS) [Time frame: Assessed as an ordinal variable from Baseline to Day 90]
  • EuroQual-5D-5L Assessment (EQ-5D-5L) [Time frame: Assessed as a continual variable from Baseline to Day 90]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742098 · NTS-521-A015-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗