NCT04527289 is a Phase 4 clinical trial of Amantadine (100mg) as add on therapy. in Trauma, Brain, sponsored by Damanhour University.

Who is sponsoring NCT04527289?

NCT04527289 is sponsored by Damanhour University.

What drugs are being tested in NCT04527289?

Interventions in NCT04527289: Amantadine (100mg) as add on therapy., Placebo.

What condition does NCT04527289 study?

NCT04527289 studies Trauma, Brain.

Is NCT04527289 still recruiting?

NCT04527289 is currently completed. Last updated 7 April 2023.

Last reviewed 2023-04-07 · How we verify

NCT04527289

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Amantadine on Traumatic Brain Injury

Completed Phase 4 Last updated 7 April 2023

What this trial tests

Phase 4 trial testing Amantadine (100mg) as add on therapy. in Trauma, Brain in 50 participants. Completed in 30 October 2021.

Timeline

30 September 2020

Primary endpoint
1 October 2021

30 October 2021

Quick facts

Lead sponsor	Damanhour University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	30 September 2020
Primary completion	1 October 2021
Estimated completion	30 October 2021
Sites	1 location across Egypt

Drugs / interventions tested

Amantadine (100mg) as add on therapy. — full drug profile →
Placebo

Conditions studied

Trauma, Brain — all drugs for Trauma, Brain →

Sponsor

Damanhour University

Who can join

Adults 18 to 75, any sex, with Trauma, Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting NMDA Receptors at the Neurovascular Unit: Past and Future Treatments for Central Nervous System Diseases.
Seillier C, Lesept F, Toutirais O, Potzeha F, et al · · 2022 · cited 26× · PMID 36142247 · DOI 10.3390/ijms231810336
Current Clinical Trials in Traumatic Brain Injury.
Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
Traumatic brain injury and immunological outcomes: the double-edged killer.
Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037

Verify or expand the search:

Other trials of Amantadine (100mg) as add on therapy.

Trials testing the same drug.

NCT06817200 — The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-b · Phase 2 · not yet recruiting

Other recruiting trials for Trauma, Brain

Currently open trials in the same condition.

NCT05855252 — PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury · recruiting
NCT05307640 — Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers · NA · recruiting
NCT04564495 — Home Based Tele-exercise for People With Chronic Neurological Impairments · NA · active not recruiting
NCT03325946 — The FBRI VTC Neuromotor Research Clinic · recruiting

Other Damanhour University trials

Trials by the same sponsor.

NCT07307911 — Coenzyme Q10 for Neuroprotection in Paclitaxel-Induced Neuropathy · Phase 2 · completed
NCT07341893 — Sacubitril-valsartan in Patients With Heart Failure. · NA · recruiting
NCT07063628 — Triglyceride-Glucose Indices and Left Ventricular Speckle Tracking in Predicting Coronary Artery Disease Severity · completed
NCT06849388 — Effect of HeartMath Intervention on Stress, Emotional Vitality and Sense of Coherence · NA · recruiting
NCT07179302 — Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04527289 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Damanhour University
Last refreshed: 7 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04527289.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing