BridgeMD
BRIGHT - 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)
EU CTIS ID: 2022-502001-15-00
What this study is testing
To determine the safety of multiple doses of LT3001 drug product in subjects with AIS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Subject has been diagnosed with AIS. 2. Subject or if applicable subject’s legally acceptable representative/ legally designated representative consents to participation by signing the informed consent form after receiving full information about the study. 3. Subject from the US and Taiwan is aged 18 to 90 years (inclusive) and subject from the EU and UK is aged 18 to 80 years (inclusive) at the time of Screening (Visit 1). 4. Subject has an NIHSS of 4 to 25. 5. Subject comes to the study site 6 hours after the stroke symptoms onset and is able to receive the 1st IP within 24 hours after stroke symptoms onset. If any subject comes to the study site within 6 hours of stroke symptoms onset and is ineligible to receive endovascular thrombectomy (EVT) and/or intravenous thrombolytic treatment (e.g., recombinant tissue-type plasminogen activator) based on the Investigator's assessment of its potential benefit. 6. Subjects who are women of childbearing potential, or men whose sexual partners are women of childbearing potential, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after the last dosing of IP administration.
You likely can't join if
- 1. During the current AIS episode, the subject has received or is scheduled to receive EVT and/or intravenous thrombolytic (e.g., recombinant tissue-type plasminogen activator) treatment based on the investigator's assessment of its potential benefit. 2. Subject has a pre-stroke disability (mRS >2). 3. Subject has Alberta Stroke Program Early CT Score of ≤5. 4. Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal. 5. In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.