Benefits of Amantadine in Patients With Coma State

Amantadine Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443037
• Other study ID #: 265-SBKAEK
• Status: Recruiting
• Start date: March 1, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2018
• Source: Dokuz Eylul University
• Contact: Kutlay Aydin, MD
• Phone: +905322649294
• Email: kutlayaydin[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amantadine
• Coma
• Coma; Prolonged

Intervention

Drug:
• amantadine sulphate

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glascow Coma Score	Glascow Coma Score	1. At the time of enrollment 2. 12 weeks after the enrollment