Disorder of ConsciousnessPhase 4NCT04427241
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
A Phase 4 study testing Cerebrolysin in people with Disorder of Consciousness and Hemorrhagic Stroke, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Disorder of Consciousness, Hemorrhagic Stroke
- What is being tested?
- Cerebrolysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hemorrhagic stroke confirmed by CT or MRI
- Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
- Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
- Age: 19 to 80 years of age
- Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.
Who cannot join
- Patients with confirmed epileptiform discharges on EEG
- Patients with brain parenchymal defects
- Patients with advanced liver, kidney, cardiac, or pulmonary disease.
- Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
- History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.
- Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
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- Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
- Administration of a contraindicated drug is essential for medical purposes.
- Contraindications to the study drug (cerebrolysin).
- Participation in another therapeutic study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center Research Coordinating Center
Seoul
Mi Soo Jang, Ph.D., 20305474 ext. +822, rcc@kuh.ac.kr
About this study
Official title: Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
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
- Conditions
- Disorder of Consciousness, Hemorrhagic Stroke
- Being tested
- Cerebrolysin, Control
- Medical subject headings
- Consciousness Disorders, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
ControlDrug
100 ml normal saline, days 4-17, once/day, IV
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin | Experimental | 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously Receives: Drug: Cerebrolysin |
| Control | Placebo comparator | 100 ml normal saline, days 4-17, once/day, IV Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Measured: 2 days after randomization
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Measured: 17 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Measured: 2 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Measured: 17 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ever Neuro Pharma GmbH
- Responsible party
- Principal investigator, Jongmin Lee, MD, PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427241
- Sponsor's protocol ID
- kuhrm2020no1
- Status last verified
- May 2026
- First submitted
- 3 Jun 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.
PubMed 32057086Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.
PubMed 22375973
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT04427241
- Acronym / sponsor ID
- kuhrm2020no1
- Conditions
- Disorder of Consciousness, Hemorrhagic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Ever Neuro Pharma GmbH
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin | Experimental | Drug: Cerebrolysin30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously |
| Control | Placebo comparator | Drug: Control100 ml normal saline, days 4-17, once/day, IV |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with hemorrhagic stroke confirmed by CT or MRI
- Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
- Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
- Age: 19 to 80 years of age
- Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.
Key exclusion criteria (10 listed)
- Patients with confirmed epileptiform discharges on EEG
- Patients with brain parenchymal defects
- Patients with advanced liver, kidney, cardiac, or pulmonary disease.
- Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
- History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrolysin30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously | Drug | Cerebrolysin |
| Control100 ml normal saline, days 4-17, once/day, IV | Drug | Control |
Primary outcome
Coma Recovery Scale - revised
Time frame: 2 days after randomization
Assessing the degree of disorders of consciousness
Coma Recovery Scale - revised
Time frame: 17 days after randomization
Assessing the degree of disorders of consciousness
Positron Emitting Tomography
Time frame: 2 days after randomization
Assessing the degree of brain neural network activity
Positron Emitting Tomography
Time frame: 17 days after randomization
Assessing the degree of brain neural network activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 32057086Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.
- Background: PubMed 22375973Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin in people with Disorder of Consciousness and Hemorrhagic Stroke, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jongmin Lee, M.D., Ph.D. (+821063558073, jongminleemd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale - revised (time frame: 2 days after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427241, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.