Citicholine-Amantadine Trial in Traumatic Brain Injury

NCT03430817 | Completed Phase 4

• 1 other identifier: FMASU R44/2017
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days

Secondary Outcomes (2)

• disability rating scale (DRS)

  30 days

• Mini Mental scale (MMS)

  30 days

Study Arms (3)

Group C

EXPERIMENTAL

Citicholine Drug

Drug: Citicholine

Group A

EXPERIMENTAL

Amantadine Drug

Drug: Amantadine

Group D

EXPERIMENTAL

Both Citocholine and Amantadine

Drug: Citicholine; Drug: Amantadine

Interventions

Citicholine 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 C; Group D

Amantadine 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 A; Group D

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained moderate non-penetrating TBI with GCS of 9-12

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Cytidine Diphosphate Choline; Amantadine

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 13, 2018
• Study Start: December 7, 2017
• Primary Completion: March 24, 2024
• Study Completion: April 20, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)