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 study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Linden Sp. z o.o. sp.k.	Cracow	Poland
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki	Lodz	Poland
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
RKH Klinken Ludwigsburg-Bietigheim gGmbH	Ludwigsburg	Germany
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
BG Klinikum Bergmannstrost Halle gGmbH	Halle (Saale)	Germany
curiositas ad sanum Studien und Beratungs GmbH	Haag in Obb	Germany
Bg Klinik	Ludwigshafen Am Rhein	Germany
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Rigshospitalet	Copenhagen	Denmark
Hopital Beaujon	Clichy	France
Hxshgmhws Myyrmqun Syrnrl	Milan	Italy
Hhigrdep Urjdfwwvgcvks Dl Lu Pxqwfcjy	Madrid	Spain
Bztydwcxfdevxpdumfiyqkujwa Uueylmfayaxvwzwnsareb Bbtifoimyrnss gkbqw	Bochum	Germany
Sabjzmu Srghbekinrrdebw Darsb Svtjtwmr W Sgprmmsvkhl	Sandomierz	Poland
Hfnprgqu Uztquibqek Cmytbbr Htmfabsr	Helsinki	Finland
Fmwlheaaa Pqux Lf Iligzdynfbzuy Buvustdro Dau Hnqskkae Uvasleivjjisx Ln Pga	Madrid	Spain
Ajtlafw Sjotj Selowgvzp Toenbfcnoewz Dwaej Vnydt Ouxxp	Saronno	Italy

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.05.2026
Finland	Not yet recruiting	01.05.2026
France	Not yet recruiting	01.05.2026
Germany	Not yet recruiting	01.05.2026
Italy	Not yet recruiting	01.05.2026
Poland	Not yet recruiting	01.05.2026
Spain	Not yet recruiting	01.05.2026
Sweden	Not yet recruiting	01.05.2026

Trial locations

Investigated drugs:

Cenegermin

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.

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 ID:

2025-522692-29-00

Protocol code:

NGF-TBI-201

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?