Impact of Amantadine on Traumatic Brain Injury

NCT04527289 | Completed Phase 4 DMC

• 1 other identifier: Amantadine on TBI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).

Conditions

Trauma, Brain

Keywords

traumatic brain injury (TBI); Interleukin-18 (IL-18); Neuron specific enolase (NSE); Neurotensin (NT)

Outcome Measures

Primary Outcomes (4)

• Neurotensin pg/ml

  Neurotensin pg/ml by ELISA Kit

  2 weeks

• Neuron specific enolase (NSE) ng/mL

  Neuron specific enolase (NSE) by ELISA Kit

  2 Weeks

• interleukin-18 (IL-18) pg/ml

  interleukin-18 (IL-18) by ELISA Kit

  2 Weeks

• ICU stay (days)

  ICU stay (days)

  6 weeks

Secondary Outcomes (2)

• (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15).

  6 weeks

• GCS-E

  6 months

Study Arms (2)

Amantadine Group

EXPERIMENTAL

Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.

Drug: Amantadine (100mg) as add on therapy.

Placebo Group

PLACEBO COMPARATOR

Group II are patients who will be managed with the standard regimen.

Drug: Placebo

Interventions

Amantadine (100mg) as add on therapy. DRUG

Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube

Also known as: PK-merz

Amantadine Group

Placebo DRUG

patients will be managed with placebo as add on to the standard regimen.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients will be enrolled if they present with clinical signs of trauma brain injury

You may not qualify if:

• Age lower than 18
• Females with positive pregnancy test
• Known congestive heart failure or ischemic heart disease
• Any injury disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias)
• Penetrating head trauma
• Need for any operation (laparotomy or craniotomy)
• Severe brain disease (For example CVA history or brain tumour)
• Renal failure with GFR lower than 60 ml/min
• Patients with unknown identity

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Elgarbia, 31527, Egypt

Location

Related Publications (3)

• Stelmaschuk S, Will MC, Meyers T. Amantadine to Treat Cognitive Dysfunction in Moderate to Severe Traumatic Brain Injury. J Trauma Nurs. 2015 Jul-Aug;22(4):194-203; quiz E1-2. doi: 10.1097/JTN.0000000000000138.

  PMID: 26165872 BACKGROUND

• Bharosay A, Bharosay VV, Varma M, Saxena K, Sodani A, Saxena R. Correlation of Brain Biomarker Neuron Specific Enolase (NSE) with Degree of Disability and Neurological Worsening in Cerebrovascular Stroke. Indian J Clin Biochem. 2012 Apr;27(2):186-90. doi: 10.1007/s12291-011-0172-9. Epub 2011 Nov 8.

  PMID: 23542317 BACKGROUND

• Ciaramella A, Della Vedova C, Salani F, Viganotti M, D'Ippolito M, Caltagirone C, Formisano R, Sabatini U, Bossu P. Increased levels of serum IL-18 are associated with the long-term outcome of severe traumatic brain injury. Neuroimmunomodulation. 2014;21(1):8-12. doi: 10.1159/000354764. Epub 2013 Sep 26.

  PMID: 24080899 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rehab H Werida, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as add on therapy. Group II are patients who will be managed with the standard regimen.

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 26, 2020
• Study Start: September 30, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)