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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091945
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Lumosa Therapeutics Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: LT3001 Drug Product Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: LT3001 Drug Product Drug: LT3001 Drug Product
Active comparator

Placebo Comparator: Placebo Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. To determine the safety of a single dose LT3001 drug product in subjects with AIS [ Time Frame: 36 hours ]
    The occurrence of symptomatic intracranial hemorrhage (sICH)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Lumosa Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT04091945    
Other Study ID Numbers: LT3001-201
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes