Health TrialsbyHealthPanel

A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
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 efficacy and safety of LT3001 in the treatment of acute ischemic stroke

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;

6 points ≤ NIHSS score ≤ 25 points at randomization;

Participants who are able to receive the investigational drug within 24 hours after the onset of stroke;

Female Participants of childbearing potential or male Participants 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;

Disqualifiers

Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period;

Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;

Neurological signs have improved rapidly and spontaneously at screening;

Participants 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

    Drug: LT3001 Drug:high dose Administered by intravenous infusion.

  • LT3001 Drug: low dose

    Drug

    Drug: LT3001 Drug: low dose Administered by intravenous infusion.

  • Placebo

    Drug

    Drug: Placebo 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: LT3001 Drug: low doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)

Time frame
Day 90 after the first dose

Secondary outcomes

1

Proportion of Participants by mRS score (0 - 2)

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

Proportion of Participants by mRS score (0 - 1)

Time frame
Day 30 after the first dose
3

mRS displacement analysis

Time frame
Day 30 and Day 90 after the first dose
4

Proportion of Participants with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score

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

This trial is not recruiting at the moment. You can still explore other options: