Evaluating LT3001 for treating acute ischemic stroke

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 study is testing if a new drug called LT3001 can help people who have had an acute ischemic stroke feel better and recover more effectively.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Locations: 28 sites (Beijing, Beijing Municipality and 27 other locations)
• Trial ID: NCT05686642 on ClinicalTrials.gov

What this trial studies

This phase II clinical study aims to assess the safety and efficacy of LT3001 in patients suffering from acute ischemic stroke. Participants will receive either a high dose of LT3001, a low dose of LT3001, or a placebo within 24 hours of stroke onset. The study will measure neurological impairment using the NIHSS score to determine the drug's effectiveness. The trial is designed to provide insights into how LT3001 can improve outcomes for stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced an acute ischemic stroke with a specific level of neurological impairment.

Not a fit: Patients who have received other stroke treatments or have disturbances of consciousness may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with acute ischemic stroke.

How similar studies have performed: While there have been studies on stroke treatments, the specific approach with LT3001 is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 27 other locations

• Beijing Luhe Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
• Luoyang Third People's Hospital — Luoyang, He'nan, China (Recruiting)
• Harrison International Peace Hospital — Hengshui, Hebei, China (Recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China (Recruiting)
• Inner Mongolia Baogang Hospital — Baotou, Inner Mongolia, China (Recruiting)
• Huai'an Second People's Hospital — Huai'an, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Beipiao Central Hospital — Chaoyang, Liaoning, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Yan'an University Xianyang Hospital — Xianyang, Shanxi, China (Recruiting)
• Xi'an Gaoxin Hospital — Xi’an, Shanxi, China (Recruiting)
• The Third Hospital of Mianyang — Mianyang, Sichuan, China (Recruiting)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Taizhou Municipal Hospital — Taizhou, Zhejiang, China (Recruiting)
• Taizhou First People's Hospital — Taizhou, Zhejiang, China (Recruiting)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
• Beijing Tsinghua Changgung Hospital — Beijing, China (Recruiting)
• Linfen Central Hospital — Linfen, China (Recruiting)
• Linfen People's Hospital — Linfen, China (Recruiting)
• Nanshi Hospital of Nanyang — Nanyang, China (Recruiting)
• Shanghai Pudong Hospital — Shanghai, China (Recruiting)
• Central People's Hospital of Zhanjiang — Zhanjiang, China (Recruiting)

Study contacts

• Study coordinator: Yongjun Wang

Conditions Acute Ischemic Stroke