Benefits of Amantadine in Patients With Coma State

• Conditions: Coma; Prolonged; Amantadine
• Interventions: Drug: amantadine sulphate

• Registration Number: NCT03443037
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amantadine group	amantadine sulphate	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

Primary Outcome Measures

Name	Time	Method
Change in Glascow Coma Score	1. At the time of enrollment 2. 12 weeks after the enrollment	Glascow Coma Score

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 Izmir, Turkey