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NCT04427241
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Phase 4 trial testing Cerebrolysin in Disorder of Consciousness in 12 participants. Status unknown.
31 July 2025
Quick facts
| Lead sponsor | Konkuk University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 June 2023 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Cerebrolysin — full drug profile →
- Control
Conditions studied
- Disorder of Consciousness — all drugs for Disorder of Consciousness →
- Hemorrhagic Stroke — all drugs for Hemorrhagic Stroke →
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):
-
Current Clinical Trials in Traumatic Brain Injury.
Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527 -
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 -
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:
- PubMed search for NCT04427241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cerebrolysin
Trials testing the same drug.
- NCT06339411 — Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights · EARLY_PHASE1 · not yet recruiting
- NCT06677502 — Cerebrolysin in Critically Ill Patients With Delirium · NA · enrolling by invitation
- NCT05755997 — CERebrolysin In CADASIL · Phase 2 · active not recruiting
- NCT06070753 — A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Str · NA · unknown
- NCT06052787 — Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU · Phase 3 · completed
Other recruiting trials for Disorder of Consciousness
Currently open trials in the same condition.
- NCT06896279 — Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousnes · NA · recruiting
- NCT06515132 — Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation · NA · recruiting
- NCT06469983 — Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial · NA · recruiting
- NCT06527573 — Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness · NA · recruiting
- NCT06635291 — Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE) · recruiting
Other Konkuk University Medical Center trials
Trials by the same sponsor.
- NCT06637943 — Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy · not yet recruiting
- NCT06144112 — Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery · Phase 4 · not yet recruiting
- NCT06664320 — Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery · NA · not yet recruiting
- NCT06574594 — Effect of MTX Discontinuation on Shingrix Response in RA · NA · recruiting
- NCT06144099 — Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04427241 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Konkuk University Medical Center
- Last refreshed: 26 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04427241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing