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Clinical Trials/NCT04427241
NCT04427241RecruitingPhase 4

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study

Konkuk University Medical Center2 sites in 2 countries12 target enrollmentStarted: June 1, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
12
Locations
2
Primary Endpoint
Positron Emitting Tomography
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).
  • •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

Arms & Interventions

Cerebrolysin

Experimental

30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously

Intervention: Cerebrolysin (Drug)

Control

Placebo Comparator

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

Intervention: Control (Drug)

Outcomes

Primary Outcomes

Positron Emitting Tomography

Time Frame: 17 days after randomization

Assessing the degree of brain neural network activity

Coma Recovery Scale - revised

Time Frame: 17 days after randomization

Assessing the degree of disorders of consciousness

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jongmin Lee, MD, PhD

Professor

Konkuk University Medical Center

Study Sites (2)

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