NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury | NCT04861688

NCT04861688

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NeuroAiD II™ (MLC901)	Active Comparator	Recommended treatment is 2 capsules orally, 3 times a day (i.e. 6 capsules per day). Treatment is 12 weeks.	Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901)
Placebo	Placebo Comparator	Capsule 2 capsules orally, 3 times a day	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Traditional Chinese Medicine (NeuroAiD II™ (MLC901)	Combination Product	NeuroAiD II™ (MLC901) contains the extracts of 9 botanical active ingredients blended with commonly used excipients. The 9 botanical active ingredients are traditional herbs well documented in the Pharmacopoeia of the People's Republic of China.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central Nervous System Vital Signs (CNS-VS), Domain score: Complex Attention	Change in complex attention score, determined using Central Nervous System Vital Signs (CNS-VS) computer cognitive testing system, after 6 months of treatment compared to baseline in the group of patients receiving NeuroAiD II™ (MLC901), compared to the placebo group. In the domain dashboard, above average domain scores indicate a Standard Score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-102 or PR 25-74, indicating normal function. Low average is SS 80-99 or PR 9-24 indicating a slight deficit or impairment. Below average is SS 70-79 or PR 2-8, indicating moderate level of deficit or impairment. Very low is SS less than 70 or a PR less than 2, indicating a deficit and impairment. Lower score is better for Complex Attention.	6 months of treatment compared to baseline

Secondary Outcomes

Measure	Description	Time Frame
CNS-VS system, Domain score: Execution Function	Changes in the scores for the following cognitive domains: executive functioning, determined by CNS-VS system, after 6 months of treatment compared to baseline, in the NeuroAiD II™ (MLC901) group, compared to the placebo group. In the domain dashboard, above average domain scores indicate a Standard Score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-102 or PR 25-74, indicating normal function. Low average is SS 80-99 or PR 9-24 indicating a slight deficit or impairment. Below average is SS 70-79 or PR 2-8, indicating moderate level of deficit or impairment. Very low is SS less than 70 or a PR less than 2, indicating a deficit and impairment. Higher score is better.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with mild TBI, which occurred 1-12 months prior enrolment to the study. Mild TBI is defined as an external force from an incident causing injury to the brain and resulting in an altered level of consciousness. The mTBI diagnosis should be documented. Mild TBI is evidenced by any of the following:
- best Glasgow Coma Score 13-15 as assessed on scene, on admission and over next 3 days
- loss of consciousness for up to 30 minutes
- dazed and confused at the time of injury or post-TBI amnesia of < 24 hours duration.
Patient experiencing cognitive impairment following injury, determined by the Cognitive Failures Questionnaire score >30.
Adult male or female patients aged 18-65 years.
The patient has signed an Informed Consent form (ICF) for participation in this study before initiation of study procedures.
The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
The patient agrees to use adequate contraception methods.

Exclusion Criteria:

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

Facility	Status	City	State	ZIP	Country	Contacts
Nizhny Novgorod regional clinical hospital named after N. A. Semashko		Nizhny Novgorod		603126	Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40638707	Derived	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.
35418437

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D008516	Medicine, Chinese Traditional
C546417	Neuroaid

ID	Term
D008518	Medicine, East Asian Traditional
D008519	Medicine, Traditional
D000529	Complementary Therapies
D013812	Therapeutics