A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
This research study is looking at a new medicine called Elezanumab for people who have recently injured their spinal cord in their neck. This type of injury can affect movement and feeling in the arms, hands, and other parts of the body. The main goal is to find out if Elezanumab is safe and if it can help improve how well people can move their arms and hands after a spinal cord injury. Participants will either receive Elezanumab or a placebo, which looks like the medicine but has no active ingredients. This helps researchers fairly compare the effects. We'll be closely watching changes in arm and hand strength. This study is an important step to see if Elezanumab could be a helpful treatment in the future.
At a glance
What is this study about?
When someone has a spinal cord injury, especially in the neck area, it can severely impact their ability to move and feel different parts of their body, particularly their arms and hands. Doctors and scientists are always looking for new ways to help people recover from these injuries and improve their quality of life. This study is testing a new medicine called Elezanumab.
The main aim of this study is to look at whether Elezanumab is safe for people who have recently had a cervical (neck) spinal cord injury and if it can help them regain movement in their arms and hands. To do this fairly, some participants will receive Elezanumab, while others will receive a 'placebo' – which looks exactly like the medicine but contains no active ingredients. This is a common way to test new medicines and helps researchers understand if any improvements are genuinely due to the medicine or other factors. Neither the participants nor their treating doctors will know who is getting which treatment during the study period.
We will be carefully measuring arm and hand movement using a standard scoring system. We will also look at how well people can do daily self-care tasks. This is an early-stage study, often called a 'Phase II' study, which means it's designed to explore whether the medicine works and is safe enough to be tested in larger groups of people later on. The hope is that this research will provide valuable information that could lead to new treatments for spinal cord injury patients in the future.
Key takeaways
- This study is testing a new medicine (Elezanumab) for neck spinal cord injuries.
- It aims to see if the medicine is safe and helps improve arm and hand movement.
- Participants will either receive the medicine or a dummy treatment (placebo).
- It's an early-stage study to gather important information for future treatments.
- Your ability to move your arms and hands will be carefully monitored.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To take part in this study, you must be at least 18 years old and of any gender. The study is specifically for people who have recently had a traumatic spinal cord injury in their neck area. This means the injury happened because of an accident or direct physical harm, not from illness or disease.
There will be other detailed medical checks to make sure the study medicine is safe for you and that the results will be clear. For example, your doctors will check your general health and how severe your spinal cord injury is. These specific requirements help make sure the study is as safe and helpful as possible for everyone involved.
If you think you might fit these general conditions, your doctor can look at the full list of requirements to see if this study is suitable for you.
- Are you 18 years old or older?
- Have you recently had a spinal cord injury in your neck?
- Was your spinal cord injury caused by an accident or physical harm (not illness)?
- Are you able to attend regular hospital/clinic visits for assessments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned to either receive the study medicine, Elezanumab, or a placebo, which looks identical but has no active ingredients. You and your doctors won't know which one you're receiving. Both Elezanumab and the placebo will be given either as an injection or through a drip (infusion) into your vein. The schedule for these treatments will be explained in detail by the study team.
You will have regular visits to the hospital or clinic where doctors and nurses will check your health, measure your arm and hand movements, and ask you questions about how you are feeling and your daily activities. These assessments are important to track any changes. The study will involve a treatment period, followed by a time where your health will continue to be monitored. The overall length of your participation, including follow-up, will be fully explained before you agree to join.
Potential risks and benefits
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Common questions
What is Elezanumab?
Elezanumab is a new medicine being tested to see if it can help people who have recently had a spinal cord injury in their neck.
What is a placebo?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare the effects of the real medicine.
Why don't I know if I'm getting the medicine or the placebo?
This is called a 'blinded' study. It helps make sure the results are fair and unbiased, as neither you nor your doctors knowing can influence the outcome.
What does 'Upper Extremity Motor Score' mean?
This is a way doctors measure how well you can move your arms and hands. It's used to see if the medicine is helping to improve strength and movement.
Can I leave the study at any time?
Yes, taking part is completely voluntary. You can choose to leave the study at any time, for any reason, and it won't affect your 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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