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).

Condition studied

Subacute Moderate to Severe Traumatic Brain Injury (TBI)

Investigational medicinal product(s)

Eligibility

Primary endpoint

1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.

Endpoint detail

1. Sliding and good outcome in Glasgow Outcome Scale – Extended at month 6., 2. Through 12 months following the first administration of investigational product., 3. Incidence of treatment-emergent serious and non-serious adverse events, and adverse events of special interest., 4. Participant incidence of study discontinuation for tolerability reasons., 5. Change from baseline on vital signs, 12-lead ECG results, clinical laboratory assessments, physical examinations, brain MRI, C-SSRS and blood levels of ADA.