Benefits of Amantadine in Patients With Coma State

D

Dokuz Eylül University (DEU)

Status

Unknown

Conditions

Coma; Prolonged
Amantadine

Treatments

Drug: amantadine sulphate

Study type

Observational

Funder types

Other

Identifiers

NCT03443037
265-SBKAEK

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

56 participants in 2 patient groups

Amantadine group
Description:
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
Treatment:
Drug: amantadine sulphate
Control group
Description:
Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin

Trial contacts and locations

1

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Central trial contact

Kutlay Aydin, MD

Data sourced from clinicaltrials.gov

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