All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

This research study is about a new medicine, JX10, for people who have recently experienced a type of stroke called an ischaemic stroke. This is when a blood clot blocks blood flow to the brain. The study wants to find out if JX10 can help improve how well people recover from their stroke and if it's safe to use. Researchers will compare JX10 with a dummy medicine (placebo) to see if there are any differences. Participants will either get JX10 or the placebo. The study is particularly looking at people who come to hospital within 4.5 to 24 hours after their stroke symptoms started.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Corxel Pharmaceuticals
Enrolment target
740
Start
15 May 2025
Estimated completion
31 Dec 2029

What is this study about?

This study is investigating a new treatment called JX10 for a specific type of stroke called an ischaemic stroke. This kind of stroke happens when a blood clot blocks an artery in the brain, stopping blood flow and damaging brain cells. The main goal of treating an ischaemic stroke is to restore blood flow as quickly as possible. This study wants to see if JX10 can help improve how well people recover after this type of stroke, especially their ability to do everyday activities. They also want to make sure it's safe to use.

The study will compare JX10 with a 'placebo', which is a dummy medicine that looks like JX10 but has no active ingredients. This helps researchers understand if any changes are truly due to JX10 or if they happen naturally or from other care. Participants won't know if they are getting JX10 or the placebo, and neither will their doctors, to keep the results fair. This study is being done in two parts: the first part will help find the best dose of JX10, and the second part will test that dose more widely.

Researchers are particularly interested in two main things: firstly, if JX10 helps people recover better in their daily lives after a stroke, and secondly, if JX10 increases the risk of serious bleeding in the brain. Understanding these points will help decide if JX10 could be a useful new treatment for people affected by stroke.

Key takeaways

  • This study tests a new medicine called JX10 for ischaemic stroke.
  • It aims to see if JX10 improves recovery and is safe.
  • Participants will receive either JX10 or a dummy medicine (placebo).
  • It's for people aged 18-90 who recently had an ischaemic stroke.
  • Close medical monitoring will be provided throughout the study.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, people need to be between 18 and 90 years old. They must have recently had an ischaemic stroke, where a blood vessel in the brain was blocked. Doctors will check scans to make sure there's brain tissue that could still be saved and that the stroke isn't too severe in other ways.

There are also some reasons why someone might not be able to join. For example, if scans show a very large area of brain damage, or if there's bleeding in the brain, or signs of a chronic blockage. People with certain serious medical conditions, like uncontrolled high blood pressure, problems with blood clotting, or a high risk of bleeding, might also not be able to take part. Recent major surgery or trauma could also exclude someone.

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.

  1. Are you between 18 and 90 years old?
  2. Have you recently had an ischaemic stroke (due to a blood clot)?
  3. Did your stroke symptoms start between 4.5 and 24 hours ago?
  4. Do your doctors believe your brain scans show tissue that could still recover?
  5. Do you have any serious medical conditions that might increase your risk of bleeding?
  6. Have you recently had major surgery or trauma?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the study medicine, JX10, or a dummy medicine called a placebo. You would have regular check-ups with the study doctors and nurses, which would include physical exams, blood tests, and brain scans. They would closely monitor your health and recovery after your stroke. The study involves several visits to the hospital or clinic, where different assessments would be done to track your progress and any side effects. The total length of your participation would be explained by the study team, including how often you would need to come in for follow-up appointments.

Potential risks and benefits

Taking part in this study could mean you receive a new medicine that might improve your recovery from stroke, though this is not guaranteed as it's still being tested. The information gathered from this study will also help doctors better understand and treat stroke in the future. However, there are potential risks, such as side effects from the medicine, including a risk of bleeding. The study team will monitor you closely for any problems. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (104)

  • Corxel Investigational Site
    Verified postcode
    Long Beach, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Sacramento, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Colorado Springs, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Washington D.C., United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Delray Beach, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Chicago, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Wichita, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Baltimore, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Kalamazoo, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    Traverse City, United States· Recruiting
  • Corxel Investigational Site
    Verified postcode
    St Louis, United States· Recruiting

Common questions

What is an ischaemic stroke?

It's a type of stroke caused by a blood clot blocking blood flow to part of the brain. This study is specifically for this kind of stroke.

What is JX10?

JX10 is the new medicine being tested in this study. We don't yet know if it helps people after a stroke, which is what the study aims to find out.

What is a placebo?

A placebo is a 'dummy' medicine that looks like JX10 but doesn't contain any active ingredients. It's used to compare against the real medicine to see if JX10 makes a difference.

Will I know if I'm getting JX10 or the placebo?

No, neither you nor your doctors will know if you're getting JX10 or the placebo during the study. This helps make the results fair and accurate.

How long will I be in the study?

The total length of time you'd be involved in the study, including follow-up appointments, would be fully explained by the study team if you're eligible and interested.

How to find out more

Corxel Pharmaceuticals Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Optimizing Reperfusion to Improve Outcomes and Neurologic Fu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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