NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

NCT04861688 | Completed Phase 3 DMC

• 1 other identifier: EFSA2020_03
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Randomized Double-blind; Placebo-controlled; NeuroAiD II™; MLC901; Traditional Chinese Medicine; Cognitive Functioning

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• CNS-VS system, Domain score: Execution Function

  after 6 months of treatment compared to baseline

• CNS-VS system, Domain score: Processing speed

  after 6 months of treatment, compared to baseline

• CNS-VS system, Domain score: Visual memory

  after 6 months of treatment, compared to baseline

• CNS-VS system, Domain score: Verbal memory

  after 6 months of treatment, compared to baseline

• CNS-VS system, Domain score: Reaction time

  after 6 months of treatment, compared to baseline

Study Arms (2)

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

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.

NeuroAiD II™ (MLC901)

Placebo OTHER

Placebo with same appearance as active intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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\*.

Sponsors & Collaborators

• Moleac Pte Ltd.: lead

Study Sites (4)

Nizhny Novgorod regional clinical hospital named after N. A. Semashko

Nizhny Novgorod, 603126, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Location

Municipal Polyclinic № 106 of St.Petersburg

Saint Petersburg, Russia

Location

X7 Research

Saint Petersburg, Russia

Location

Related Publications (2)

• 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.

  PMID: 40638707 DERIVED

• 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.

  PMID: 35418437 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Medicine, Chinese Traditional; Neuroaid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 27, 2021
• Study Start: August 23, 2021
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)