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Combination Treatment With Cerebrolysin and Amantadine on Patients Who Stays in Prolonged Disorders of Consciousness Due to Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427241
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Ever Neuro Pharma GmbH
Information provided by (Responsible Party):
Jongmin Lee, MD, PhD, Konkuk University Medical Center

Brief Summary:
Object: To demonstrate the combined effect of cerebrolysin and amantadine on prolonged disorders of consciousness in patients with severe traumatic brain injury Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury Intervention: amantadine only (100mg to 200mg bid) or cerebrolysin only (30ml qd) or amantadine (100mg to 200mg bid) plus cerebrolysin (30ml qd) Comparison: amantadine only group versus cerebrolysin only group versus amantadine plus cerebrolysin group Outcome: Coma Recovery Scale-revised, FDG-PET signal

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Disorder of Consciousness Drug: Amantadine Sulfate plus Cerebrolysin Drug: Amantadine Sulfate Drug: Cerebrolysin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Treatment With Cerebrolysin and Amantadine on Prolonged Disorders of Consciousness in Patients With Severe Traumatic Brain Injury: A Pilot Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amantadine plus cerebrolysin Drug: Amantadine Sulfate plus Cerebrolysin
Amantadine plus cerebrolysin : amantadine 100mg to 200mg bid plus cerebrolysin 30ml qd
Other Name: Cerebrolysin only

Active Comparator: Amantadine only Drug: Amantadine Sulfate
Amantadine only : amantadine 100mg to 200mg bid

Active Comparator: Cerebrolysin only Drug: Cerebrolysin
Cerebrolysin only : cerebrolysin 30ml qd




Primary Outcome Measures :
  1. Coma Recovery Scale - revised [ Time Frame: 2 days after randomization ]
    Assessing the degree of consciousness impairment after traumatic brain injury

  2. Coma Recovery Scale - revised [ Time Frame: 8 days after randomization ]
    Assessing the degree of consciousness impairment after traumatic brain injury

  3. Coma Recovery Scale - revised [ Time Frame: 22 days after randomization ]
    Assessing the degree of consciousness impairment after traumatic brain injury

  4. Positron Emitting Tomography [ Time Frame: 2 days after randomization ]
    Assessing the degree of brain neural network activity

  5. Positron Emitting Tomography [ Time Frame: 8 days after randomization ]
    Assessing the degree of brain neural network activity

  6. Positron Emitting Tomography [ Time Frame: 22 days after randomization ]
    Assessing the degree of brain neural network activity



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with Severe traumatic brain injury (GCS ≤8, best available score within 24hrs)
  • TBI Confirmed with CT or MRI
  • at least 4 weeks after traumatic event
  • vegetative state or minimally conscious state secondary to TBI (assessed by CRS-R)
  • Patient between 19 and 64 years of age
  • Written informed consent obtained from the patient or legally authorized representative

Exclusion Criteria:

  • with epileptiform discharge confirmed by EEG
  • with hydrocephalus
  • with parenchymal defect
  • with advanced liver, kidney, cardiac or pulmonary disease
  • with history of advanced cancer within 2 years
  • history of alcohol or substance abuse or dependence within the past two years (DSM-V criteria)
  • any significant systemic illness (or unstable medical condition that could lead to difficulties complying with the protocol
  • history of treatment with antidepressants, antipsychotic drugs, nootropic drugs, vasodilators
  • contraindication from amantadine or cerebrolysin
  • current enrolment in another therapeutic study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427241


Locations
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Korea, Republic of
Konkuk University Medical Center Research Coordinating Center
Seoul, Korea, Republic of
Contact: Mi Soo Jang, Ph.D.    20305474 ext +822    rcc@kuh.ac.kr   
Sponsors and Collaborators
Konkuk University Medical Center
Ever Neuro Pharma GmbH
Publications:
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Responsible Party: Jongmin Lee, MD, PhD, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT04427241    
Other Study ID Numbers: kuhrm2020no1
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Consciousness Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders
Amantadine
Cerebrolysin
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents
Nootropic Agents