Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515591-12-00

Acronym

C-RETURN

Enrollment

440

Registered

2024-08-27

Start date

2024-08-27

Completion date

Unknown

Last updated

2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Brief summary

Glasgow Outcome Scale Extended (GOSE) outcome at 90 days after baseline

Detailed description

efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 10,45, 90 and 180 days after baseline.

Interventions

DRUGCEREBROLYSIN

DRUGSer fiziologic 90 mg/10 ml solvent pentru uz parenteral

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Glasgow Outcome Scale Extended (GOSE) outcome at 90 days after baseline	—

Secondary

Measure	Time frame
efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 10,45, 90 and 180 days after baseline.	—

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026