Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

February 19, 2024 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in Subjects With Acute Ischemic Stroke (AIS)

This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
      • Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
      • Linfen, China
        • Recruiting
        • Linfen Central Hospital
        • Contact:
          • Hongguo Dai
      • Linfen, China
        • Recruiting
        • Linfen People's Hospital
        • Contact:
          • Junfang Hao
      • Nanyang, China
        • Recruiting
        • Nanshi Hospital of Nanyang
        • Contact:
          • Bin Liu
      • Shanghai, China
        • Recruiting
        • Shanghai Fifth People's Hospital
        • Contact:
          • Danhong Wu
      • Shanghai, China, 201399
        • Recruiting
        • Shanghai Pudong Hospital
        • Contact:
      • Zhanjiang, China
        • Recruiting
        • Central People's Hospital of Zhanjiang
        • Contact:
          • Hui Mai
    • Anhui
      • Bengbu, Anhui, China, 233099
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 101199
        • Recruiting
        • Beijing Luhe Hospital Capital Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:
    • Hebei
      • Hengshui, Hebei, China, 053099
        • Recruiting
        • Harrison International Peace Hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The Third Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Recruiting
        • Daqing Oilfield General Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471002
        • Recruiting
        • Luoyang Third People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014017
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College
        • Contact:
          • Bo Liu
      • Baotou, Inner Mongolia, China, 750306
        • Recruiting
        • Inner Mongolia Baogang Hospital
        • Contact:
          • Dong Wang
    • Jiangsu
      • Huai'an, Jiangsu, China, 223022
        • Recruiting
        • Huai'an Second People's Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337000
        • Recruiting
        • PingXiang People's Hospital
        • Contact:
    • Jilin
      • Chang chun, Jilin, China, 136199
        • Recruiting
        • Guowen Medical Corporation Jilin Guowen Hospital
        • Contact:
      • Changchun, Jilin, China, 130061
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
    • Liaoning
      • Chaoyang, Liaoning, China, 122199
        • Recruiting
        • Beipiao Central Hospital
        • Contact:
    • Shandong
      • Liaocheng, Shandong, China, 252004
        • Recruiting
        • LiaoCheng People's Hospital
        • Contact:
      • Tai'an, Shandong, China, 271099
        • Recruiting
        • Taian City Central Hospital
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710077
        • Recruiting
        • Xi'an Gaoxin Hospital
        • Contact:
      • Xianyang, Shanxi, China, 716099
        • Recruiting
        • Yan'an University Xianyang Hospital
        • Contact:
    • Sichuan
      • Mianyang, Sichuan, China
        • Recruiting
        • The Third Hospital of Mianyang
        • Contact:
          • Diwen Zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • Recruiting
        • Zhejiang Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 314408
        • Recruiting
        • Zhejiang provincial people's hospital
        • Contact:
          • Shunyuan Guo
      • Taizhou, Zhejiang, China, 318020
        • Recruiting
        • Taizhou First People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China, 318000
        • Recruiting
        • Taizhou Municipal hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged between 18 and 80 years at screening;
  2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;

4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.

Exclusion Criteria:

  1. Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
  2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
  3. Neurological signs have improved rapidly and spontaneously at screening;
  4. Subjects who have used or are using protocol-prohibited medications after the onset;
  5. Subjects with pre-stroke disability;
  6. Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment;
  7. Massive infarction on imaging;
  8. Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
  9. Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg after active antihypertensive therapy;
  10. Acute hemorrhage tendency;
  11. Blood glucose level < 50 mg/dL or > 400 mg/dL;
  12. Active visceral hemorrhage;
  13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results;
  14. International normalized ratio > 1.7 or prothrombin time > 15 s;
  15. Subjects with a history of serious hypersensitivity;
  16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
  17. Subjects who underwent any major surgery before screening;
  18. Subjects with a history of active digestive ulcer before screening;
  19. Subjects who experienced hemorrhagic disease before screening;
  20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
  21. Serious hepatic impairment or serious renal insufficiency;
  22. Subjects who have participated in another investigational study and used investigational product before screening;
  23. Other conditions unsuitable for participation in this study determined by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered by intravenous infusion.
Experimental: LT3001 Drug:high dose
Drug: LT3001 Drug:high dose
Administered by intravenous infusion.
Experimental: LT3001 Drug:low dose
Drug: LT3001 Drug:low dose
Administered by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Adverse Events
Time Frame: Approximately 2 years
Adverse event type, incidence, duration, correlation with study drug
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)
Time Frame: Day 30 and Day 90 after the first dose
Proportion of subjects by mRS score (0 - 2)
Day 30 and Day 90 after the first dose
Proportion of subjects with an NIHSS（National Institute of Health stroke scale ） score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Time Frame: Day 14 after the first dose
Proportion of subjects with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Day 14 after the first dose
Absolute change from baseline in NIHSS score
Time Frame: Day 3、Day 7、Day 14 and Day 30 after the first dose
Absolute change from baseline in NIHSS score
Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points
Time Frame: Day 30 and Day 90 after the first dose
Proportion of subjects with a BI score of ≥ 95 points and ≥ 75 points
Day 30 and Day 90 after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding 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 Major Dates

Study Start (Actual)

April 6, 2023

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

July 12, 2025

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-LT3001-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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