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A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LT3001 Drug Product
Placebo
Sponsored by
Lumosa Therapeutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Kentucky Chandler Medical CenterRecruiting
  • JFK Neuroscience Institute, JFK Medical CenterRecruiting
  • The Ohio State University - Wexner Medical CenterRecruiting
  • Chattanooga Center for Neurologic ResearchRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Linkou Chang Gung Memorial HospitalRecruiting
  • Taipei Medical University - Shuang Ho HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LT3001 Drug Product

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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 symptomatic intracranial hemorrhage (sICH) between LT3001 drug product and Placebo.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
September 11, 2020
Sponsor
Lumosa Therapeutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04091945
Brief Title
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
Official Title
A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumosa Therapeutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LT3001 Drug Product
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LT3001 Drug Product
Intervention Description
Active comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
The percentage of subject have symptomatic intracranial hemorrhage (sICH) of a single dose LT3001 drug product in subjects with AIS.
Description
Compare the the percentage of subject having symptomatic intracranial hemorrhage (sICH) between LT3001 drug product and Placebo.
Time Frame
Within 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 90 years NIHSS of 4 to 30 Diagnosis of AIS within 24 hours after stroke symptoms onset Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Yeh
Phone
+886 2 26557918
Ext
5735
Email
sabrina_yeh@lumosa.com.tw
Facility Information:
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
JFK Neuroscience Institute, JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Chattanooga Center for Neurologic Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

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