RECRUITING

A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT).

Official Title

A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)

Quick Facts

Study Start:2022-08-11

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05198323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study. 2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1). 3. Subject has an NIHSS ≥6. 4. Subject is eligible to be treated with EVT within 24 hours after stroke symptoms onset. Subject has no severe contrast allergy or absolute contraindication to iodinated contrast preventing EVT, including any contraindications listed in the prescribing information approved by local regulatory authorities. 5. Subject is able to receive the investigational product before EVT and within 24 hours after stroke symptoms onset. 6. Subjects who are women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after dosing of investigational product.	1. Subject has been treated or intent to treat with intravenous thrombolytic during the current AIS, e.g., recombinant tissue-type plasminogen activator (rtPA). 2. Subject has been treated with EVT before investigational product administration during the current AIS. 3. Subject has a pre-stroke disability that requires help for activities of daily living (mRS ≥2). 4. Subject has large ischemic core volume \>70 mL or Alberta Stroke Program Early CT Score (ASPECTS) of ≤5. 5. Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal. 6. Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor (except small meningioma), arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment. 7. Subject has significant mass effect with midline shift. 8. Subject has intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device. 9. Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations, e.g., seizures at onset of the current AIS, dementia. 10. Subject has current uncontrolled hypertension despite treatment: systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg before dosing at Screening (Visit 1). 11. Subject has hemorrhagic diathesis, coagulation factor deficiency or recent oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7 or activated partial thromboplastin time (aPTT) \>3 times of upper limit of normal range at Screening (Visit 1). 12. Subject has received one of the new oral anticoagulants within 48 hours before treatment, e.g., dabigatran, apixaban. 13. Subject has platelet count \<100,000/mm 3 at Screening (Visit 1). 14. Subject has hemoglobin \<7 mmol/L at Screening (Visit 1). 15. Subject has abnormal sodium concentration \<130 mmol/L and/or potassium concentration \<3 mEq/L or \>6 mEq/L at Screening (Visit 1). 16. Subject has blood glucose concentration \<50 mg/dL or \>400 mg/dL at Screening (Visit 1). 17. Subject has severe hepatic, renal, and/or active infectious disease at Screening (Visit 1). 18. Subject is lactating, pregnant (pregnancy test required for all female subjects of childbearing potential), or planning to become pregnant during the study. 19. Subject has had prior AIS, myocardial infarction, or serious head trauma within 90 days of Screening (Visit 1). 20. Subject has history of ICH within 90 days of Screening (Visit 1). 21. Subject has had any major surgery within 90 days of Screening (Visit 1), e.g., intracranial or intraspinal surgery, coronary artery bypass graft, obstetrical delivery, organ biopsy. 22. Subject has had a bleeding event within 21 days of Screening (Visit 1), e.g., gastrointestinal or hemorrhage. 23. Subject has puncture of noncompressible vessels within 7 days of Screening (Visit 1). 24. Subject has participated in another investigational study and received investigational product within 30 days of Screening (Visit 1) or 5 half-lives (whichever is longer). 25. In the opinion of the Investigator, the subject is precluded from EVT procedure, or a significant hazard is posed to the subject if EVT procedure is performed. 26. In the opinion of the Investigator, the subject has serious, advanced, or terminal illness that will prevent improvement or follow-up visits. 27. In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.

Inclusion Criteria

Exclusion Criteria

1. Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1).
3. Subject has an NIHSS ≥6.
4. Subject is eligible to be treated with EVT within 24 hours after stroke symptoms onset. Subject has no severe contrast allergy or absolute contraindication to iodinated contrast preventing EVT, including any contraindications listed in the prescribing information approved by local regulatory authorities.
5. Subject is able to receive the investigational product before EVT and within 24 hours after stroke symptoms onset.
6. Subjects who are women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after dosing of investigational product.

1. Subject has been treated or intent to treat with intravenous thrombolytic during the current AIS, e.g., recombinant tissue-type plasminogen activator (rtPA).
2. Subject has been treated with EVT before investigational product administration during the current AIS.
3. Subject has a pre-stroke disability that requires help for activities of daily living (mRS ≥2).
4. Subject has large ischemic core volume \>70 mL or Alberta Stroke Program Early CT Score (ASPECTS) of ≤5.
5. Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
6. Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor (except small meningioma), arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
7. Subject has significant mass effect with midline shift.
8. Subject has intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device.
9. Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations, e.g., seizures at onset of the current AIS, dementia.
10. Subject has current uncontrolled hypertension despite treatment: systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg before dosing at Screening (Visit 1).
11. Subject has hemorrhagic diathesis, coagulation factor deficiency or recent oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7 or activated partial thromboplastin time (aPTT) \>3 times of upper limit of normal range at Screening (Visit 1).
12. Subject has received one of the new oral anticoagulants within 48 hours before treatment, e.g., dabigatran, apixaban.
13. Subject has platelet count \<100,000/mm 3 at Screening (Visit 1).
14. Subject has hemoglobin \<7 mmol/L at Screening (Visit 1).
15. Subject has abnormal sodium concentration \<130 mmol/L and/or potassium concentration \<3 mEq/L or \>6 mEq/L at Screening (Visit 1).
16. Subject has blood glucose concentration \<50 mg/dL or \>400 mg/dL at Screening (Visit 1).
17. Subject has severe hepatic, renal, and/or active infectious disease at Screening (Visit 1).
18. Subject is lactating, pregnant (pregnancy test required for all female subjects of childbearing potential), or planning to become pregnant during the study.
19. Subject has had prior AIS, myocardial infarction, or serious head trauma within 90 days of Screening (Visit 1).
20. Subject has history of ICH within 90 days of Screening (Visit 1).
21. Subject has had any major surgery within 90 days of Screening (Visit 1), e.g., intracranial or intraspinal surgery, coronary artery bypass graft, obstetrical delivery, organ biopsy.
22. Subject has had a bleeding event within 21 days of Screening (Visit 1), e.g., gastrointestinal or hemorrhage.
23. Subject has puncture of noncompressible vessels within 7 days of Screening (Visit 1).
24. Subject has participated in another investigational study and received investigational product within 30 days of Screening (Visit 1) or 5 half-lives (whichever is longer).
25. In the opinion of the Investigator, the subject is precluded from EVT procedure, or a significant hazard is posed to the subject if EVT procedure is performed.
26. In the opinion of the Investigator, the subject has serious, advanced, or terminal illness that will prevent improvement or follow-up visits.
27. In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.

Contacts and Locations

Study Contact

Claire Sun

CONTACT

+886-2-26557918

claire_sun@lumosa.com.tw

Study Locations (Sites)

CHI Memorial Hospital

Chattanooga, Tennessee, 37404

United States

Collaborators and Investigators

Sponsor: Lumosa Therapeutics Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-11

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-08-11

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Acute Ischemic Stroke