NCT04091945

Brief Summary

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

December 30, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

September 5, 2019

Results QC Date

December 10, 2025

Last Update Submit

January 20, 2026

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.

    Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.

    Within 36 hours

Study Arms (2)

LT3001 Drug Product

ACTIVE COMPARATOR
Drug: LT3001 Drug Product

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LT3001 Drug ProductDRUG

Active comparator

LT3001 Drug Product
PlaceboDRUG

Placebo comparator

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 90 years
  • NIHSS of 4 to 30
  • Diagnosis of AIS within 24 hours after stroke symptoms onset

You may not qualify if:

  • Treatement with approved drug during the current AIS
  • Pre-stroke disability
  • Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
  • Suspected subarachnoid hemorrhage
  • Seizure
  • Uncontrolled hypertension
  • INR \>1.7 and/or abnormal aPTT or platelet count \<100,000/mm3
  • Blood glucose concentration \<50 mg/dL or \>400 mg/dL
  • Lactating or pregnant subjects or those planning to become pregnant during the study
  • Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
  • AIS, myocardial infarction, serious head trauma or major surgery within 90 days
  • Bleeding event within 21 days
  • Puncture of noncompressible vessels within 7 days
  • Severe hepatic, renal, and/or infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

JFK Neuroscience Institute, JFK Medical Center

Edison, New Jersey, 08837, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, 37403, United States

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Linkou Chang Gung Memorial Hospital

New Taipei City, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Chao AC, Lee TH, Pettigrew LC, Hannawi Y, Huang HY, Chi NF, Chan L, Chen PL, Devlin T. Intravenous Odatroltide for Acute Ischemic Stroke Within 24 Hours of Onset: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Drug Des Devel Ther. 2024 Jun 6;18:2033-2042. doi: 10.2147/DDDT.S460831. eCollection 2024.

    PMID: 38859883DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Sabrina Yeh
Organization
Lumosa Therapeutics Co., Ltd.
sabrina_yeh@lumosa.com.tw
+886 2 26557918

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 17, 2019

Study Start

January 27, 2020

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

January 22, 2026

Results First Posted

December 30, 2025

Record last verified: 2026-01

Locations

US(4)TW(6)