Citicholine-Amantadine Trial in Traumatic Brain Injury

NCT ID: NCT03430817

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2024-04-20

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

Conditions

Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group C

Citicholine Drug

Group Type: EXPERIMENTAL

Citicholine

Intervention Type: DRUG

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.

Group A

Amantadine Drug

Group Type: EXPERIMENTAL

Amantadine

Intervention Type: DRUG

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.

Group D

Both Citocholine and Amantadine

Group Type: EXPERIMENTAL

Citicholine

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dina Salah Eldin Mahmoud Badre

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R44/2017

Identifier Type: -

Identifier Source: org_study_id