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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LT3001 Drug:high dose

    Drug

    Administered by intravenous infusion.

  • Placebo

    Drug

    Administered by intravenous infusion.

  • LT3001 Drug:low dose

    Drug

    Administered by intravenous infusion.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: LT3001 Drug:high doseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: LT3001 Drug:low doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence Adverse Events

Adverse event type, incidence, duration, correlation with study drug

Time frame
Approximately 2 years

Secondary outcomes

1

Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)

Proportion of subjects by mRS score (0 - 2)

Time frame
Day 30 and Day 90 after the first dose
2

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

Time frame
Day 14 after the first dose
3

Absolute change from baseline in NIHSS score

Absolute change from baseline in NIHSS score

Time frame
Day 3、Day 7、Day 14 and Day 30 after the first dose
4

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

Time frame
Day 30 and Day 90 after the first dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pharmaceuticals Holding Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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