A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects (NCT05403866) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
United States89 participantsStarted 2022-08-17
Plain-language summary
This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is aged 18 to 90 years.
✓. Subject has an NIHSS of 6 to 25.
✓. Subject is able to receive the first IP within 24 hours after stroke symptoms onset.
✓. Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
✓. Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL.
Exclusion criteria
✕. Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
✕. Subject has a pre-stroke disability (mRS ≥2).
✕. Subject has large ischemic core volume \>70 mL or ASPECTS ≤5.
✕. Subject has symptoms of suspected subarachnoid hemorrhage.
✕. Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
✕. Subject has significant mass effect with midline shift.
✕. Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
What they're measuring
1
The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
Timeframe: within 90 days after the first IP administration