The effects of amantadine on traumatic brain injury outcome: a double-blind, randomized, controlled, clinical trial

Abstract

Introduction: Amantadine, as a dopamine receptor agonist, may stimulate and help the recovery of the nervous system after traumatic brain injury (TBI).

Methods: We performed this study as a double-blind, randomized, controlled clinical trial with target population including all patients with TBI who scored nine or lower on the Glasgow Coma Scale (GCS), admitted to our hospital between January 2013 and April 2014. The protocol included administration of the drug (placebo or amantadine) for 6 weeks and patient evaluation using the GCS and FOUR score on the first, third and seventh days after the drug was started. After 6 months from starting study drug, the patients were evaluated on the Mini-Mental State Examination, Glasgow Outcome Study, Disability Rating Scale and Karnofsky Performance Scale.

Results: We included 40 patients in the study. The mean age of the patients was 36.77 ± 18.21. As an only important finding, the amantadine group registered an important rise between the first and the seventh day of study drug (∆GCS7-GCS1) with p-value = 0.044.

Conclusion: Based on our findings during the first week and the 6 months (since starting drug) follow-ups, prescribing amantadine did not lead to reportable effects on the patients' level of consciousness, memory, disability, cognition, mortality and performance.

Keywords: Traumatic brain injury; amantadine; double-blind method; outcome assessment.