Benefits of Amantadine in Patients With Coma State

NCT03443037 | Unknown FDA Drug

• 1 other identifier: 265-SBKAEK
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Coma; Prolonged; Amantadine

Keywords

Coma; Disability; amantadine

Outcome Measures

Primary Outcomes (1)

• Change in Glascow Coma Score

  Glascow Coma Score

  1. At the time of enrollment 2. 12 weeks after the enrollment

Study Arms (2)

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

Interventions

amantadine sulphate DRUG

Amantadine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ≥18 years, ≤ 65 years
• GCS score ≤ 8
• Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coma

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Necati Gokmen, MD

  Dokuz Eylul University

  STUDY CHAIR

• Kutlay Aydin

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Kutlay Aydin

  Dokuz Eylul University

  STUDY DIRECTOR

• Begum Ergan

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kutlay Aydin, MD

CONTACT

+905322649294; kutlayaydin@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff in the department of pulmonary and critical care medicine

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)