Citicholine-Amantadine Trial in Traumatic Brain Injury

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Intensive Care Unit

Treatments: Drug: Citicholine; Drug: Amantadine

Study type: Interventional

Funder types: Other

Identifiers

NCT03430817

FMASU R44/2017

Details and patient eligibility

About

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).

Full 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

Enrollment: 45 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Group C

Experimental group

Description:

Citicholine Drug

Treatment:

Drug: Citicholine

Group A

Experimental group

Description:

Amantadine Drug

Treatment:

Drug: Amantadine

Group D

Experimental group

Description:

Both Citocholine and Amantadine

Treatment:

Drug: Amantadine

Drug: Citicholine