Back to resultsCiticholine-Amantadine Trial in Traumatic Brain Injury
Primary Purpose
Intensive Care Unit
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Citicholine
Amantadine
Sponsored by
About this trial
This is an interventional treatment trial for Intensive Care Unit
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.
Sites / Locations
- Ain Shams University hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group C
Group A
Group D
Arm Description
Citicholine Drug
Amantadine Drug
Both Citocholine and Amantadine
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03430817
Brief Title
Citicholine-Amantadine Trial in Traumatic Brain Injury
Official Title
Citicholine-Amantadine Trial in Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Experimental
Arm Description
Citicholine Drug
Arm Title
Group A
Arm Type
Experimental
Arm Description
Amantadine Drug
Arm Title
Group D
Arm Type
Experimental
Arm Description
Both Citocholine and Amantadine
Intervention Type
Drug
Intervention Name(s)
Citicholine
Intervention Description
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
Intervention Name(s)
Amantadine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Galsgow coma scale
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
disability rating scale (DRS)
Description
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.
Time Frame
30 days
Title
Mini Mental scale (MMS)
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Citicholine-Amantadine Trial in Traumatic Brain Injury
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