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Proof-of-Concept Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of Intranasal Cenegermin in Adult Participants with moderate to severe Traumatic Brain Injury (TBI).
EU CTIS ID: 2025-522692-29-00
What this study is testing
To evaluate the safety and tolerability of intranasal cenegermin in participants with moderate to severe subacute TBI.
- 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. Male and female adults 18 to 70 years of age.
- 2. TBI resulting in hospital evaluation within the last 2-8 weeks prior to informed consent
- 3. A clinical diagnosis of moderate to severe TBI (defined by Glasgow Coma Scale [GCS] score 3 to 12), considering the highest GCS score assessed within 24 hours following injury
- 4. Confirmed TBI diagnosis by computed tomography (CT) assessed by the investigator
- 5. Anticipated discharge to a rehabilitation setting within a facility or at home.
You likely can't join if
- 1. GOS-E score of 7 (lower good recovery) or 8 (upper good recovery) at time of informed consent.
- 2. Penetrating TBI (eg, gunshot, stabs).
- 3. Medically refractory brain edema at time of screening.
- 4. Dependence on invasive mechanical ventilation without the ability to sustain spontaneous breathing at time of screening.
- 5. Poor survival prognosis (investigator assessment).
- 6. Pre-existing medical conditions which can continue to produce functional disability up to the time of injury.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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.