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)
The BRIGHT study is looking into a new medicine called LT3001 for adults who have recently experienced a type of stroke called Acute Ischemic Stroke (AIS). This is a 'Phase 2' study, which means it’s an early step where researchers are mainly checking if the new medicine is safe and if it shows signs of working. Participants will receive either the new medicine or a 'dummy' treatment (placebo), without knowing which one they are getting. The study aims to see how well people recover and to record any side effects within 90 days of starting treatment. It’s designed to help us understand if LT3001 could be a helpful treatment for stroke in the future.
At a glance
What is this study about?
The BRIGHT study is exploring a new treatment called LT3001 for a condition known as Acute Ischemic Stroke, often simply called a stroke. This type of stroke happens when a blood clot blocks blood flow to a part of the brain. When this occurs, brain cells can be damaged, leading to various health problems depending on which part of the brain is affected. Finding new ways to help people after a stroke is really important to improve their recovery and quality of life.
This study is in Phase 2, which means it’s an important step after initial safety tests in a small group of people. In this phase, researchers are trying to find out more about the safety of LT3001 and if it has any positive effects on people who have had a stroke. Think of it like taking a new car for a test drive – you want to see if it handles well, is reliable, and if it's safe to use before it's offered to everyone.
To make sure the results are fair and accurate, some participants will receive the actual LT3001 medicine, while others will receive a 'placebo'. A placebo looks exactly like the medicine but contains no active ingredients. Neither the participants nor the doctors will know who is getting which treatment until after the study is complete. This helps to make sure that any improvements or side effects observed are truly due to the medicine being tested, rather than other factors.
Key takeaways
- The BRIGHT study is testing a new medicine, LT3001, for people who have recently had a stroke.
- It's a Phase 2 study, focused on safety and early signs of how well the medicine works.
- Participants will receive either the new medicine or a dummy treatment (placebo).
- Both men and women aged 18 and over, who have had a stroke, may be eligible.
- The study involves regular visits and follow-up for about 90 days after starting treatment.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for the BRIGHT study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate. The study is open to both men and women.
Beyond these basic requirements, the specific details of your stroke and your overall health condition will be carefully reviewed by the study doctors. This is to make sure the study is a good fit for you and that taking part would be safe. For example, they might look at how long ago your stroke happened, or if you have certain other health conditions.
The doctors and nurses involved in the study will explain all the requirements in detail and answer any questions you have. They will help determine if you meet all the necessary criteria to join the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently had an Acute Ischemic Stroke?
- Are you able to attend regular hospital/clinic visits?
- Are you comfortable with the idea of potentially receiving a placebo?
- Are you willing to follow the study's treatment and visit schedule?
What does participation involve?
If you decide to take part in the BRIGHT study, you would receive either the new medicine, LT3001, or a placebo (a dummy treatment). These would be given over a set period. You wouldn't know whether you're getting the active medicine or the placebo.
During the study, you would have regular visits to the hospital or clinic. These appointments are important for the study team to check your health, see how you are responding to the treatment, and monitor for any side effects. These visits might include physical examinations, blood tests, and other assessments related to your stroke recovery.
After you have finished receiving the medicine, doctors will continue to follow up with you for about 90 days after your first dose. This follow-up ensures that any longer-term effects or side effects are recorded. The total time you would be involved in the study, from starting treatment to the final check-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (6)
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Common questions
What is a 'Phase 2' study?
Phase 2 is an early stage of testing a new medicine. It focuses on finding out if the medicine is safe and if it shows signs of working, after initial safety tests.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used to compare against the new medicine.
What is Acute Ischemic Stroke (AIS)?
AIS is a common type of stroke caused by a blood clot blocking blood flow to part of the brain.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know who is receiving the active medicine until the study is over.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, without it affecting your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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