Clinical trial NCT04427241: Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Official title: Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Disorder of Consciousness
Hemorrhagic Stroke
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Ever Neuro Pharma GmbH
First posted: 2020-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 ml normal saline, days 4-17, once/day, IV

Comparison: cerebrolysin group versus control group

Outcome: Coma Recovery Scale-revised, FDG-PET signal


Eligibility criteria: Inclusion Criteria

1. Patients with hemorrhagic stroke confirmed by CT or MRI
2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
4. Age: 19 to 80 years of age
5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.

Exclusion Criteria

1. Patients with confirmed epileptiform discharges on EEG
2. Patients with brain parenchymal defects
3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.
4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
5. 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.
6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
8. Administration of a contraindicated drug is essential for medical purposes.
9. Contraindications to the study drug (cerebrolysin).
10. Participation in another therapeutic study

Primary outcomes:
measure: Coma Recovery Scale - revised
timeFrame: 2 days after randomization
measure: Coma Recovery Scale - revised
timeFrame: 17 days after randomization
measure: Positron Emitting Tomography
timeFrame: 2 days after randomization
measure: Positron Emitting Tomography
timeFrame: 17 days after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center Research Coordinating Center
Study officials:
References:
citation: 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.
citation: Giacino 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.