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

NCT07742098 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NTS-521-A015-201
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; AIS; Ischemic Stroke; Stroke

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  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

Secondary Outcomes (4)

• Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)

  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)

  Assessed as a continuous variable from baseline to Day 90

• Modified Rankin Score (mRS)

  Assessed as an ordinal variable from Baseline to Day 90

• EuroQual-5D-5L Assessment (EQ-5D-5L)

  Assessed as a continual variable from Baseline to Day 90

Study Arms (4)

Placebo 0.9% saline solution

PLACEBO COMPARATOR

0.9% saline solution

Other: Placebo Control

Low Dose NTS-521

EXPERIMENTAL

Low Dose NTS-521 in 0.9% saline delivered IV

Drug: NTS-521

Medium Dose NTS-521

EXPERIMENTAL

Medium Dose NTS-521 in 0.9% saline delivered IV

Drug: NTS-521

High Dose NTS-521

EXPERIMENTAL

High Dose NTS-521 in 0.9% saline delivered IV

Drug: NTS-521

Interventions

NTS-521 DRUG

Intravenous NTS-521

High Dose NTS-521; Low Dose NTS-521; Medium Dose NTS-521

Placebo Control OTHER

0.9% saline solution delivered intravenously

Placebo 0.9% saline solution

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NeuroTrauma Sciences, LLC: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bijoy A Menon, MD

  The University of Calgary Stroke Program & Stroke Clinical Trial Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott C Oshana, BS

CONTACT

18603022074; s.oshana@neurotraumasciences.com

Allison Ward, MSA, MSEd

CONTACT

910-616-8586; a.ward@neurotraumasciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor, Clinical Monitors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled parallel-arm trial to evaluate the safety and effect of three IV doses of NTS-521 vs placebo for the early recovery treatment of Acute Ischemic Stroke (AIS).

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share