Status:
COMPLETED
Citicholine-Amantadine Trial in Traumatic Brain Injury
Lead Sponsor:
Ain Shams University
Conditions:
Intensive Care Unit
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- Sustained moderate non-penetrating TBI with GCS of 9-12
Exclusion
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03430817
Start Date
December 7 2017
End Date
April 20 2024
Last Update
May 24 2024
Active Locations (1)
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1
Ain Shams University hospitals
Cairo, Egypt, 11591