Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686642
• Other study ID #: SPH-LT3001-202
• Status: Recruiting
• Phase: Phase 2
• Start date: April 6, 2023
• Est. completion date: July 12, 2025

Study information

• Verified date: February 2024
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: Yongjun Wang
• Phone: 0086-010-59978538
• Email: Yongjunwang111[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 12, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• LT3001 Drug:high dose
Administered by intravenous infusion.
• Placebo
Administered by intravenous infusion.
• LT3001 Drug:low dose
Administered by intravenous infusion.

Locations

Country	Name	City	State
China	Inner Mongolia Baogang Hospital	Baotou	Inner Mongolia
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Luhe Hospital Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	Guowen Medical Corporation Jilin Guowen Hospital	Chang chun	Jilin
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Beipiao Central Hospital	Chaoyang	Liaoning
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harrison International Peace Hospital	Hengshui	Hebei
China	Huai'an Second People's Hospital	Huai'an	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Linfen Central Hospital	Linfen
China	Linfen People's Hospital	Linfen
China	Luoyang Third People's Hospital	Luoyang	Henan
China	The Third Hospital of Mianyang	Mianyang	Sichuan
China	Nanshi Hospital of Nanyang	Nanyang
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai Fifth People's Hospital	Shanghai
China	Shanghai Pudong Hospital	Shanghai
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Taian City Central Hospital	Tai'an	Shandong
China	Taizhou First People's Hospital	Taizhou	Zhejiang
China	Taizhou Municipal Hospital	Taizhou	Zhejiang
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Xi'an Gaoxin Hospital	Xi'an	Shanxi
China	Yan'an University Xianyang Hospital	Xianyang	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Central People's Hospital of Zhanjiang	Zhanjiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Adverse Events	Adverse event type, incidence, duration, correlation with study drug	Approximately 2 years
Secondary	Proportion of subjects by mRS(Modified Rankin Scale) score (0 - 2)	Proportion of subjects by mRS score (0 - 2)	Day 30 and Day 90 after the first dose
Secondary	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	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
Secondary	Absolute change from baseline in NIHSS score	Absolute change from baseline in NIHSS score	Day 3?Day 7?Day 14 and Day 30 after the first dose
Secondary	Proportion of subjects with a BI(Barthel index) score of = 95 points and = 75 points	Proportion of subjects with a BI score of = 95 points and = 75 points	Day 30 and Day 90 after the first dose