Citicholine-Amantadine Trial in Traumatic Brain Injury

Intensive Care Unit Clinical Trial

Official title:

Citicholine-Amantadine Trial in Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430817
• Other study ID #: FMASU R44/2017
• Status: Completed
• Phase: Phase 4
• Start date: December 7, 2017
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 20, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Intensive Care Unit

Intervention

Drug:
• Citicholine
Patients will receive 1 gram (2 vials of citicholine; each 500 mg) every 12 hours given slowly intravenous over 10 minutes for 7 days then oral form of the drug will be used. Participants who can swallow will receive 500-mg (5ml volume; 100mg/ml) oral drops (syrup) twice a day. Participants who cannot swallow will receive the same dose as oral drops syrup of citicoline through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube in a total dose of 1000 mg/day for the remainder of the 30 days study period.
• Amantadine
Patients will receive 200 mg of amantadine sulphate in a 500 ml solution every 12 hours by slow intravenous infusion over a period of 4 hours for 7 days then oral form will be used. Participants who can swallow will receive two 100-mg tablets twice a day. Participants who cannot swallow will receive the tablets of amantadine through a NG tube or PEG tube as 400 mg via crushed tablets with a 25-mL saline or water flush for the remainder of the 30 days study period.

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Galsgow coma scale	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).	30 days
Secondary	disability rating scale (DRS)	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.	30 days
Secondary	Mini Mental scale (MMS)	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.	30 days