Citicholine-Amantadine Trial in Traumatic Brain Injury

PHASE4CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

March 24, 2024

Study Completion Date

April 20, 2024

Conditions
Intensive Care Unit
Interventions
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.

DRUG

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.

Trial Locations (1)

11591

Ain Shams University hospitals, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT03430817 - Citicholine-Amantadine Trial in Traumatic Brain Injury | Biotech Hunter | Biotech Hunter