Citicholine-Amantadine Trial in Traumatic Brain Injury

Phase 4

Completed

• Conditions: Intensive Care Unit
• Interventions: Drug: Citicholine; Drug: Amantadine

• Registration Number: NCT03430817
• Lead Sponsor: Ain Shams University

Brief Summary

This randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate Traumatic Brain injury (TBI).

Detailed Description

As both agents amantadine and citcholine showed considerable effects on neuro-recovery from TBI, The investigators hypothesized that combination therapy of both drugs will have significant effect as it simultaneously will target multiple mechanisms of injury. So, this randomized study aims at comparing between the effects of amantadine, citcholine and their combinations on arousal and behavioral consequences in early phase of moderate TBI

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-13
• Primary Completion: 2024-03-24
• Study Completion: 2024-04-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Sustained moderate non-penetrating TBI with GCS of 9-12

Exclusion Criteria

• Patients with mild (GCS > 12) or severe TBI (GCS < 9)
• Patients suffering from any central nervous system disability prior to the traumatic brain injury
• Major medical problems as; major cardiovascular disease or heart failure, renal insufficiency (creatinine clearance, less than 60 ml per minute), liver impairment,
• Pregnancy,
• More than one seizure in the previous month,
• Prior treatment with amantadine,
• Allergy to the study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Citicholine	Citicholine Drug
Group D	Citicholine	Both Citocholine and Amantadine
Group D	Amantadine	Both Citocholine and Amantadine
Group A	Amantadine	Amantadine Drug

Primary Outcome Measures

Name	Time	Method
Galsgow coma scale	30 days	Neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment. A patient is assessed against the criteria of the scale, and the resulting points give a patient score between 3 (indicating deep unconsciousness) and 15 (full conscious).

Secondary Outcome Measures

Name	Time	Method
disability rating scale (DRS)	30 days	The Disability Rating Scale (DRS) was developed and tested with older juvenile and adult individuals with moderate and severe traumatic brain injury (TBI). The maximum score a patient can obtain on the DRS is 29 (extreme vegetative state). A person without disability would score zero. The DRS rating must be reliable, i.e., obtained while the individual is not under the influence of anesthesia, other mind-altering drugs, recent seizure, or recovering from surgical anesthesia.
Mini Mental scale (MMS)	30 days	The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.; Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt