Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)

Phase 2/3 Completed 184 enrolled JFK Medical Center U.S. Department of Education · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2003-02
Primary completion: 2010-03
Completion: 2010-03

Outcome

Met primary endpoint

paper recovery was significantly faster in the amantadine group than in the placebo group, as measured by the DRS score PMID 22375973 ↗

registry Amantadine vs Placebo; p = 0.007; Slope -0.24 (95% CI -0.41 to -0.07) NCT00970944 ↗

Publications

Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amantadine	Unknown	200 mg	—