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NCT04427241

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Status unknown Phase 4 Last updated 26 May 2023
What this trial tests

Phase 4 trial testing Cerebrolysin in Disorder of Consciousness in 12 participants. Status unknown.

Timeline
1 June 2023
Primary endpoint
31 July 2025
31 December 2025

Quick facts

Lead sponsorKonkuk University Medical Center
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment12
Start date1 June 2023
Primary completion31 July 2025
Estimated completion31 December 2025
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Konkuk University Medical Center

Who can join

Adults 19 to 120, any sex, with Disorder of Consciousness or Hemorrhagic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke. Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV Comparison: cerebrolysin group versus control group Outcome: Coma Recovery Scale-revised, FDG-PET signal

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current Clinical Trials in Traumatic Brain Injury.
    Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
  2. Therapy of traumatic brain injury by modern agents and traditional Chinese medicine.
    Wei C, Wang J, Yu J, Tang Q, et al · · 2023 · cited 15× · PMID 36906602 · DOI 10.1186/s13020-023-00731-x
  3. Restoring consciousness with pharmacologic therapy: Mechanisms, targets, and future directions.
    Barra ME, Solt K, Yu X, Edlow BL. · · 2024 · cited 11× · PMID 39019729 · DOI 10.1016/j.neurot.2024.e00374

Verify or expand the search:

Other trials of Cerebrolysin

Trials testing the same drug.

Other recruiting trials for Disorder of Consciousness

Currently open trials in the same condition.

Other Konkuk University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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