At a glance
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Amantadine Hydrochloride for Treatment of Symptoms of the Post-traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Amantadine hydrochloride and Placebo capsule for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 79 participants across 1 site.
Detailed Summary
Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion. Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.
Study Details
Timeline
Interventions
100mg administered orally twice daily x 14 days
capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days