NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

Summary

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

Timeline

Start

2021-08-23

Primary completion

2023-02-14

Completion

2023-02-14

Publications

• Pilipenko PI, Ivanova AA, Kotsiubinskaya YV, Grigoryeva VN, Khrulev AY, Skorokhodov AV, Gavrik MM, Mkrtchan NN, Majdan M, Valkovic P, Rabarova D, Barker-Collo S, Jones K, Feigin VL. A double-blind, placebo-controlled, randomized, multi-centre, phase III study of MLC901 (NeuroAiDTMII) for the treatment of cognitive impairment after mild traumatic brain injury. PLoS One. 2025 Jul 10;20(7):e0310229. doi: 10.1371/journal.pone.0310229. eCollection 2025.
• Pilipenko P, Ivanova AA, Kotsiubinskaya YV, Feigin V, Majdan M, Grigoryeva VN, Khrulev AY. Randomised, double-blind, placebo-controlled study investigating Safety and efficAcy of MLC901 in post-traUmatic bRAin Injury: the SAMURAI study protocol. BMJ Open. 2022 Apr 13;12(4):e059167. doi: 10.1136/bmjopen-2021-059167.

Drugs

Indications