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Benefits of Amantadine in Patients With Coma State

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ClinicalTrials.gov Identifier: NCT03443037
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Begum Ergan, Dokuz Eylul University

Brief Summary:
The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.

Condition or disease Intervention/treatment
Coma; Prolonged Amantadine Drug: amantadine sulphate

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Group/Cohort Intervention/treatment
Amantadine group
Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician
Drug: amantadine sulphate
Control group
Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin



Primary Outcome Measures :
  1. Change in Glascow Coma Score [ Time Frame: 1. At the time of enrollment 2. 12 weeks after the enrollment ]
    Glascow Coma Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.
Criteria

Inclusion Criteria:

  • ≥18 years, ≤ 65 years
  • GCS score ≤ 8
  • Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion Criteria:

  • <18 years, > 65 years
  • Patients admitted to the critical care without diagnosis of coma state
  • Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
  • Metastatic malignant neoplazm
  • Congenital or acquired brain function problem (cerebral palsy, autism etc)
  • Patients with amantadine allergy
  • Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)

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): NCT03443037


Contacts
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Contact: Kutlay Aydin, MD +905322649294 kutlayaydin@hotmail.com

Locations
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Turkey
Dokuz Eylul University Recruiting
Izmir, Turkey
Contact: Kutlay Aydin, MD    +905322649294    kutlayaydin@hotmail.com   
Contact: Zehra Mermi, MD    +905331680832    zehramermi@gmail.com   
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Study Chair: Necati Gokmen, MD Dokuz Eylul University
Principal Investigator: Kutlay Aydin Dokuz Eylul University
Study Director: Kutlay Aydin Dokuz Eylul University
Principal Investigator: Begum Ergan Dokuz Eylul University

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Responsible Party: Begum Ergan, Staff in the department of pulmonary and critical care medicine, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03443037     History of Changes
Other Study ID Numbers: 265-SBKAEK
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Begum Ergan, Dokuz Eylul University:
Coma
Disability
amantadine
Additional relevant MeSH terms:
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Amantadine
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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