Benefits of Amantadine in Patients With Coma State

September 5, 2018 updated by: Begum Ergan, Dokuz Eylul University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glascow Coma Score
Time Frame: 1. At the time of enrollment 2. 12 weeks after the enrollment
Glascow Coma Score
1. At the time of enrollment 2. 12 weeks after the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 265-SBKAEK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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