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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-80
SponsorNeuroTrauma Sciences, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NTS-521
  • Placebo Control

Treatment groups

140 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators