Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pharmaceuticals Holding Co., Ltd
About this trial
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LT3001 Drug:high dose
- Placebo
- LT3001 Drug:low dose
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov