Citicholine-Amantadine Trial in Traumatic Brain Injury

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03430817

Collaborator

(none)

Enrollment

Location

Arms

11.8

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit	Drug: Citicholine Drug: Amantadine	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Citicholine-Amantadine Trial in Traumatic Brain Injury

Actual Study Start Date :

Dec 7, 2017

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group C Citicholine Drug	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.
Experimental: Group A Amantadine Drug	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.
Experimental: Group D Both Citocholine and Amantadine	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.

Arm

Intervention/Treatment

Experimental: Group C

Citicholine Drug

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.

Experimental: Group A

Amantadine Drug

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.

Experimental: Group D

Both Citocholine and Amantadine

Drug: Citicholine

Drug: Amantadine

Outcome Measures

Primary Outcome Measures

Galsgow coma scale [30 days]
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) [30 days]
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) [30 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina Salah Eldin Mahmoud Badre, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03430817

Other Study ID Numbers:

FMASU R44/2017

First Posted:

Feb 13, 2018

Last Update Posted:

Feb 13, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Amantadine

Cytidine Diphosphate Choline

Study Results

No Results Posted as of Feb 13, 2018