Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).
This research study is looking into a new nasal spray treatment called Cenegermin for adults who have recently experienced a moderate to severe traumatic brain injury (TBI). We are especially interested in understanding if the spray is safe to use and how well people can tolerate it. We'll be closely monitoring participants for any side effects, both serious and not serious, for six months after they start the treatment. This study is in an early stage (Phase II) and also aims to find the right dose of Cenegermin and see how the body handles it. Ultimately, we hope to learn if Cenegermin could help people recover from head injuries.
At a glance
What is this study about?
This research is focused on adults who have recently had a moderate to severe head injury, also known as a traumatic brain injury or TBI. A TBI happens when a sudden injury causes damage to the brain, and it can affect how someone thinks, feels, and moves. This study is testing a new treatment which is a nasal spray called Cenegermin. Cenegermin contains a special protein called nerve growth factor, which is naturally found in the body and helps nerve cells grow and survive.
We are in the early stages of testing this new treatment, which means we first need to make sure it's safe and that people can tolerate it without too many problems. We'll also be trying to understand how Cenegermin works in the body and if there's an ideal amount to give to people. The main goal for this part of the study is to carefully watch for any side effects, big or small, that might happen up to six months after someone starts using the spray. We're comparing Cenegermin to a 'vehicle,' which is a spray that looks exactly the same but doesn't contain the active medicine.
By gathering all this information, we hope to learn if Cenegermin could be a helpful new treatment option for people recovering from a head injury. Understanding its safety and how it affects the body is a crucial step before it can be considered for wider use.
Key takeaways
- This study is testing a nasal spray (Cenegermin) for adults with recent moderate to severe head injuries.
- The main focus is to check the safety of the spray and how well people tolerate it over six months.
- Participants will receive either Cenegermin or a dummy spray; neither they nor the doctors will know which.
- Regular check-ups, blood tests, and brain scans will be part of the study.
- Your participation will last up to 12 months.
- The aim is to help find better treatments for head injuries in the future.
Who may be eligible?
This study is looking for volunteers who are adults, meaning they must be 18 years old or older. There is no upper age limit for taking part.
Both men and women are welcome to participate in this research. The most important condition for joining is that you have recently had a moderate to severe traumatic brain injury. Specific details about the timing and type of head injury would be discussed with the study team to ensure you meet all requirements.
Before you can join, the study doctors will check your medical history and do some tests to make sure the study is a safe and suitable option for you. They will explain everything clearly, and you'll have the chance to ask any questions.
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 experienced a moderate to severe head injury?
- Are you able to attend appointments regularly for up to a year?
- Are you comfortable having various medical tests, including blood tests and brain scans?
What does participation involve?
If you decide to take part in this study, you will be given either the new Cenegermin nasal spray or a 'vehicle' spray (which doesn't contain the active medicine). You won't know which one you are receiving, and neither will your study doctor, which helps us to get unbiased results. You will use the nasal spray as directed by the study team.
Over the course of the study, you'll have several visits to the clinic for check-ups. These visits will involve various assessments, including physical examinations, checking your vital signs (like blood pressure and heart rate), taking blood and urine samples, and having scans of your brain (MRI). We will also ask you questions about how you are feeling, including any side effects you might experience, and assess your recovery using a special scale called the Glasgow Outcome Scale – Extended. Your emotional well-being will also be checked. These checks will happen regularly for up to six months after you start the spray, and some follow-up will continue for a full year to monitor your long-term health. The total duration of your participation, including follow-up, will be 12 months.
Potential risks and benefits
Locations (8)
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Common questions
What is a 'nasal spray' Cenegermin?
Cenegermin is a new medicine in the form of a nasal spray that contains a protein aiming to help nerve cells. This study is testing it for head injuries.
What does 'moderate to severe Traumatic Brain Injury (TBI)' mean?
This refers to an injury to the brain that is quite serious and may lead to lasting problems. The study focuses on people who have recently had such an injury.
Will I know if I'm getting the actual medicine or a dummy spray?
No, neither you nor your study doctor will know if you're getting Cenegermin or the dummy (vehicle) spray. This is to ensure fair results.
How long will I be involved in the study?
You'll be involved for up to 12 months, with close monitoring for the first six months after starting the spray.
What kind of tests will I have during the study?
You'll have physical checks, blood tests, heart tests (ECG), brain scans (MRI), and be asked about your recovery and feelings.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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