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Phase 2a Study of Safety, Tolerability and Efficacy of Intranasal Cenegermin in Adults with Moderate to Severe Subacute Traumatic Brain Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A study is focused on adults who have experienced a Traumatic Brain Injury that is in the sub‑acute phase, meaning several weeks to months after the initial event, and that is classified as moderate to severe because of the extent of damage. The experimental treatment is an intranasal spray containing cenegermin, a form of recombinant human Nerve Growth Factor that is intended to support the growth and repair of nerve cells. Participants receive either the spray or a matching inactive spray (placebo), and the main goal of the research is to determine whether the spray can be used safely and is tolerated by people with this type of brain injury.

After a short period of daily dosing, participants are monitored over the course of up to a year. Follow‑up visits include checks of vital signs, blood tests, a brain scan using MRI, and a heart rhythm test called a ECG. Functional recovery is assessed with a questionnaire called the Glasgow Outcome Scale – Extended, which helps gauge the ability to perform everyday activities. Throughout the study, any side effects or health problems are recorded, and participants may stop the treatment if it becomes intolerable. The study concludes after the final follow‑up assessment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After consent, you are assigned by the study system to receive either cenegermin (the investigational product) or vehicle (placebo). the assignment is random and double‑blinded, meaning neither you nor the study staff know which product you receive.

  2. Step 2

    Baseline assessments

    Before the first dose, you undergo a series of examinations that include measurement of vital signs, a 12‑lead electrocardiogram (ecg), clinical laboratory tests, a physical examination, and a brain magnetic resonance imaging (mri) scan. these results establish your health status at the start of the trial.

  3. Step 3

    First intranasal administration

    You receive the first dose of the assigned intranasal spray. the spray contains cenegermin (recombinant human nerve growth factor) or the inactive vehicle. each dose is 00 µg (micrograms) in a powder that is dissolved for nasal inhalation. the route of administration is intranasal use.

  4. Step 4

    Daily intranasal dosing period

    You continue to administer the assigned intranasal spray according to the schedule defined in the study protocol. the dosing continues throughout the study period, which includes follow‑up visits up to twelve months after the first administration.

  5. Step 5

    Scheduled follow‑up visits

    You attend study visits at predefined intervals to allow the study team to monitor safety and efficacy. the visits are typically scheduled at week 2, month 1, month 3, month 6, and month 12 after the first dose.

    At each visit you will have vital signs measured, an ecg performed, laboratory tests drawn, and a physical examination. brain mri may be repeated at month 6 and month 12. questionnaires such as the Glasgow Outcome Scale‑Extended and the Columbia‑Suicide Severity Rating Scale (c‑ssrs) may be completed.

  6. Step 6

    Adverse‑event reporting

    Throughout the trial you are instructed to report any new or worsening symptoms, known as adverse events, to the study staff. both serious and non‑serious events are recorded for safety evaluation.

  7. Step 7

    Final evaluation

    At the month 12 visit a comprehensive assessment is performed, including the final set of safety measurements, efficacy outcomes, and laboratory analyses. the collected data determine the overall safety, tolerability, and potential benefit of the intranasal product.

Who can join the trial?

5 criteria

  • Be an adult between 18 and 70 years old, regardless of gender.
  • Have suffered a traumatic brain injury (TBI) that led to a hospital visit within the past 2 to 8 weeks before agreeing to join the study.
  • Have a doctor’s diagnosis of moderate to severe TBI, which means the injury was serious enough to receive a Glasgow Coma Scale (GCS) score of 3 to 12 during the first 24 hours after the injury (the GCS is a simple test that rates eye, verbal, and motor responses).
  • Have a brain scan called a computed tomography (CT) that confirms the presence of the injury, as reviewed by the study investigator.
  • Be expected to leave the hospital and go to a rehabilitation setting, either a rehab facility or home, after discharge.

Who cannot join the trial?

6 criteria

  • If your recovery rating (called the GOS‑E score) is already at the highest levels (7 or 8) when you give consent, you cannot take part. The GOS‑E is a scale that measures how well someone is recovering after a brain injury.
  • If you have a penetrating TBI, meaning the injury was caused by something that went through the skull (for example, a gunshot wound or a stabbing), you cannot join the study.
  • If you have stubborn brain swelling (known as brain edema) that does not improve with treatment at the time of screening, you cannot participate.
  • If you need a breathing machine (invasive mechanical ventilation) and cannot breathe on your own at the time of screening, you are not eligible.
  • If the doctor judges that you have a poor survival prognosis, meaning a low chance of surviving, you cannot be included.
  • If you have other ongoing health problems that already cause disability before the brain injury (pre‑existing medical conditions), you cannot take part.
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Investigated drugs

Cenegermin is a medicine made from a natural protein that helps nerves grow and heal. In this trial it is given as a nasal spray that you put into the nose. The goal is to see if giving this medicine after a moderate to severe traumatic brain injury can be safe, be well‑tolerated, and help the brain recover better.

What is already known about the treatment

  • Cenegermin

    This investigational product is supplied as a nasal spray powder that is mixed with water to create an intranasal solution; it is already approved for a rare eye condition (neurotrophic keratitis) and is now being studied for brain injury treatment; the drug is intended for adults with moderate to severe subacute traumatic brain injury; it works by binding to TrkA receptors on nerve cells, encouraging neuron survival and growth, and is classified as a recombinant neurotrophic factor.

  • Vehicle

    The vehicle is an inert intranasal spray containing only the non‑active ingredients used to deliver the medication; it acts as a placebo in this trial and has no therapeutic effect; it is not a marketed drug and therefore does not appear in standard medical references; its purpose is to provide a neutral carrier so that participants and investigators remain blinded to treatment allocation.

Investigated diseases

Subacute Moderate to Severe Traumatic Brain Injury - This condition refers to a brain injury that occurs after a significant blow or jolt to the head and is observed during the sub‑acute phase, typically days to weeks after the event. The injury is categorized as moderate to severe based on the initial level of consciousness and neurological signs. Over time, individuals may notice changes in memory, attention, and thinking abilities. Physical abilities such as balance, coordination, and strength can become increasingly affected. Emotional responses like irritability, mood swings, or anxiety may also develop as the brain continues to heal. The pattern of symptoms can evolve, with some improving while others persist or appear later.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522692-29-00Protocol codeNGF-TBI-201Estimated enrolment168 patientsSponsorDompe' Farmaceutici S.p.A.

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