NCT05686642
Recruiting
Phase 2
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)
Shanghai Pharmaceuticals Holding Co., Ltd46 sites in 1 country300 target enrollmentStarted: April 6, 2023Last updated:
ConditionsAcute Ischemic Stroke
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 46
- Primary Endpoint
- Incidence Adverse Events
Overview
Brief Summary
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged between 18 and 80 years at screening;
- •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
- •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;
- •Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- •Neurological signs have improved rapidly and spontaneously at screening;
- •Subjects who have used or are using protocol-prohibited medications after the onset;
- •Subjects with pre-stroke disability;
- •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;
- •Massive infarction on imaging;
- •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;
- •Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy;
- •Acute hemorrhage tendency;
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
LT3001 Drug:high dose
Experimental
Intervention: LT3001 Drug:high dose (Drug)
LT3001 Drug:low dose
Experimental
Intervention: LT3001 Drug:low dose (Drug)
Outcomes
Primary Outcomes
Incidence Adverse Events
Time Frame: Approximately 2 years
Adverse event type, incidence, duration, correlation with study drug
Secondary Outcomes
- Proportion of subjects by mRS（Modified Rankin Scale） 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(Day 14 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(Day 30 and Day 90 after the first dose)
Investigators
Study Sites (46)
Loading locations...
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