Benefits of Amantadine in Patients With Coma State

NCT ID: NCT03443037

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coma; Prolonged Amantadine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

amantadine sulphate

Intervention Type DRUG

Control group

Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin

No interventions assigned to this group

Interventions

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amantadine sulphate

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Begum Ergan

Staff in the department of pulmonary and critical care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Necati Gokmen, MD

Role: STUDY_CHAIR

Dokuz Eylul University

Kutlay Aydin

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Kutlay Aydin

Role: STUDY_DIRECTOR

Dokuz Eylul University

Begum Ergan

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kutlay Aydin, MD

Role: CONTACT

+905322649294

Facility Contacts

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Kutlay Aydin, MD

Role: primary

+905322649294

Zehra Mermi, MD

Role: backup

+905331680832

Other Identifiers

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265-SBKAEK

Identifier Type: -

Identifier Source: org_study_id

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