Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study

Summary

The purpose of this study is to study the effect of amantadine on irritability and aggression caused by traumatic brain injury.

Timeline

Start

2009-08

Primary completion

2013-04

Completion

2013-05

Outcome

Missed primary endpoint

registry analysis (other test); Amantadine vs Placebo; p = 0.9554; Difference in percents -0.4 (95% CI -14.7 to 13.9); Chi-squared NCT00779324 ↗

Publications

• Hammond FM, Zafonte RD, Sherer M, Bell KR, Bogner J, Malec JF, Tang Q, Jang JH. Assessing the benefits and risks of amantadine for irritability and aggression after traumatic brain injury. PM R. 2024 Jul;16(7):661-668. doi: 10.1002/pmrj.13122. Epub 2024 Feb 20.
• Hammond FM, Sherer M, Malec JF, Zafonte RD, Dikmen S, Bogner J, Bell KR, Barber J, Temkin N. Amantadine Did Not Positively Impact Cognition in Chronic Traumatic Brain Injury: A Multi-Site, Randomized, Controlled Trial. J Neurotrauma. 2018 Oct 1;35(19):2298-2305. doi: 10.1089/neu.2018.5767. Epub 2018 Jun 7.
• Hammond FM, Malec JF, Zafonte RD, Sherer M, Bogner J, Dikmen S, Whitney MP, Bell KR, Perkins SM, Moser EA. Potential Impact of Amantadine on Aggression in Chronic Traumatic Brain Injury. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):308-318. doi: 10.1097/HTR.0000000000000342.
• Hammond FM, Sherer M, Malec JF, Zafonte RD, Whitney M, Bell K, Dikmen S, Bogner J, Mysiw J, Pershad R; Amantadine Irritability Multisite Study Group. Amantadine Effect on Perceptions of Irritability after Traumatic Brain Injury: Results of the Amantadine Irritability Multisite Study. J Neurotrauma. 2015 Aug 15;32(16):1230-8. doi: 10.1089/neu.2014.3803. Epub 2015 Mar 31.

Drugs

Indications