Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study.
Seunghwan Lee, Hyun Haeng Lee, Yejin Lee...
https://pubmed.ncbi.nlm.nih.gov/32057086Actively Recruiting
Phase 4
Age: 19Years - 120Years
All Genders
ID04427241
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
Led by Konkuk University Medical Center · Updated on 2026-05-11
12
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
K
Konkuk University Medical Center
Lead Sponsor
E
Ever Neuro Pharma GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Cerebrolysin on patients with prolonged disorders of consciousness caused by hemorrhagic stroke. This pilot phase 4 study focuses on patients who have been in a vegetative or minimally conscious state for more than four weeks following their stroke. The study aims to assess the safety and efficacy of Cerebrolysin treatment compared to a placebo control group. Participants receive either 30 ml of Cerebrolysin combined with 70 ml of normal saline or 100 ml of normal saline alone. Both treatments are administered intravenously once daily from days 4 to 17 after randomization. The study uses a randomized and quadruple-blinded design to compare these two groups. During the study, participants will be evaluated using the Coma Recovery Scale-Revised and Positron Emission Tomography (PET) scans at two time points: 2 days and 17 days after randomization. The research team will monitor changes in consciousness levels and brain metabolism. The total study duration includes the treatment period and follow-up assessments up to day 17.
CONDITIONS
Brief Title
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Who Can Participate
Age: 19Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with hemorrhagic stroke confirmed by CT or MRI
- Patients with disorders of consciousness lasting more than 4 weeks after hemorrhagic stroke onset
- Patients in a vegetative state or minimally conscious state based on Coma Recovery Scale-Revised
- Age between 19 and 80 years
- Voluntary written informed consent given by the patient or legal representative
You will not qualify if you...
- Presence of epileptiform discharges on EEG
- Brain parenchymal defects
- Advanced liver, kidney, heart, or lung disease
- Chronic use of medications affecting consciousness such as antidepressants, antipsychotics, nootropics, or vasodilators
- History of serious illness in the last 2 years including cancer, hematologic, renal, hepatic, coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy
- Alcohol or drug abuse or dependence within the last 2 years
- Significant systemic disease or unstable medical condition affecting study compliance
- Necessity of contraindicated drugs for medical purposes
- Contraindications to cerebrolysin
- Participation in another therapeutic study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants receive daily intravenous infusions of either Cerebrolysin or placebo from day 4 to day 17 after randomization.
Daily visits for 14 days
Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center Research Coordinating Center
Seoul, South Korea
Actively Recruiting
Loading map...
Research Team
J
Jongmin Lee, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Placebo-controlled trial of amantadine for severe traumatic brain injury.
Joseph T Giacino, John Whyte, Emilia Bagiella...
https://pubmed.ncbi.nlm.nih.gov/22375973