At a glance
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A Multicenter Prospective Randomized Controlled Trial of the Effectiveness of Amantadine Hydrochloride in Promoting Recovery of Function Following Severe Traumatic Brain Injury
In Brief
A Phase 3 clinical trial evaluating Amantadine Hydrochloride and Placebo for Traumatic Brain Injury. Completed, enrolled 184 participants across 11 sites in 3 countries.
Detailed Summary
This is a controlled trial of amantadine to improve level of function following severe traumatic brain injury. The purpose of this study is: 1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves functional recovery from the vegetative and minimally conscious states 2. To determine whether amantadine-related gains in function persist following drug discontinuation 3. To determine the safety profile of amantadine in patients with disorders of consciousness
Study Details
Timeline
Interventions
184 patients who remain in VS or MCS 4 - 16 weeks post-TBI will be randomized in a stratified fashion to 4 weeks of amantadine (200 - 400 mg/day) followed by a 2-week washout period. The Disability Rating Scale (DRS) will be the primary dependent variable with the Coma Recovery Scale-Revised (CRS-R) serving as a supplementary measure.
Placebo administered twice daily.