NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

Inclusion Criteria:

1. Patient with mild TBI, which occurred 1-12 months prior enrolment to the study. MildTBI is defined as an external force from an incident causing injury to the brain andresulting in an altered level of consciousness. The mTBI diagnosis should bedocumented. Mild TBI is evidenced by any of the following:

• best Glasgow Coma Score 13-15 as assessed on scene, on admission and over next 3days
• loss of consciousness for up to 30 minutes
• dazed and confused at the time of injury or post-TBI amnesia of < 24 hoursduration.

2. Patient experiencing cognitive impairment following injury, determined by theCognitive Failures Questionnaire score >30.
3. Adult male or female patients aged 18-65 years.
4. The patient has signed an Informed Consent form (ICF) for participation in this studybefore initiation of study procedures.
5. The patient can understand all protocol requirements, perform the study procedures,and agree to all limitations specified in the protocol.
6. The patient agrees to use adequate contraception methods.

Exclusion Criteria:

1. Moderate or Severe TBI, determined by best Glasgow Coma Score of <13 (as assessed onscene, on admission and over next 3 days), or injury requiring neurosurgery (even ifsurgery was not done)
2. Co-existing severe co-morbidity, including end stage renal failure, spinal cordinjury, significant substance abuse, severe liver disease, significant mentalillnesses, diabetes requiring insulin injections, severe agitation, advanced cancer orother severe conditions with life expectancy of less than 5 years. The decision onsignificance of the comorbidity for inclusion/exclusion from current study is made bythe Investigator.
3. Current participation in another clinical trial within 30 days.
4. Women who are pregnant or who have a positive urine pregnancy test or breast-feeding.
5. Not fluent in Russian language or have aphasia/dysphasia.
6. No documented evidence of mTBI.
7. Known allergy to MLC901/NeuroAiD II™ or any of its component ingredients.
8. Other medical condition which in the opinion of the Principal Investigator would placeundue risk on the patient if included in the trial or likely to interfere withNeuroAiD II™.
9. History of psychic (including depressive) disorders, physical and other factors thatdo not allow for adequate self-assessment of one's behaviour and for compliance withthe protocol requirements, including history of psychiatric disorders.
10. Use of hormonal contraceptives, either oral or implant*.