erve growth factor in pediatric severe traumatic brain injury : translational and clinical studies on a candidate biomarker and therapeutic drug

Phase 1

• Conditions: Persistent unresponsive wakefulness syndrome (UWS); MedDRA version: 20.1Level: LLTClassification code 10049615Term: Late effects of head traumaSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-002282-35-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Children (aged between 6 months and 5 years) who satisfy all the following criteria:
-specific brain lesions, such as Diffuse Axonal injury (DAI) or other brain lesions secondary to traumatic brain injuries, as documented by brain MRI or brain CT scan
-severe cognitive, motor and neurosensory deficits resulting from traumatic brain lesions, as measured by the sensorimotor score ASIA-IMSOP Classification”
-all neurological deficits have to be stabilized, unresponsive to any treatment in place and have a clinical, neuroradiological and instrumental documentation that supports the diagnosis of UWS. In any case, the neurological deficit must be characterized by severe neurosensory, cognitive and motor deficits. We will use the sensorimotor scale ASIA-IMSOP; EEG recordings; Functional rating performed with SCIM (Spinal Cord Independence Measure), Version III
-written informed consent signed by the parents or by legally appointed guardians.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Intraparenchymal hemorrhages
-intraventricular hemorrhages
-subdural hematomas
-epidural hematomas.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified