NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

NCT ID: NCT04861688

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2023-02-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NeuroAiD II™ (MLC901)

Recommended treatment is 2 capsules orally, 3 times a day (i.e. 6 capsules per day). Treatment is 12 weeks.

Group Type: ACTIVE_COMPARATOR

Traditional Chinese Medicine (NeuroAiD II™ (MLC901)

Intervention Type: 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.

Placebo

Capsule 2 capsules orally, 3 times a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo with same appearance as active intervention

Interventions

Traditional Chinese Medicine (NeuroAiD II™ (MLC901)

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

Placebo with same appearance as active intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient experiencing cognitive impairment following injury, determined by the Cognitive 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 study before 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 on scene, on admission and over next 3 days), or injury requiring neurosurgery (even if surgery was not done)

2. 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.

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 place undue risk on the patient if included in the trial or likely to interfere with NeuroAiD II™.

9. 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.

10. Use of hormonal contraceptives, either oral or implant*.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moleac Pte Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Nizhny Novgorod, , Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , Russia

Municipal Polyclinic № 106 of St.Petersburg

Saint Petersburg, , Russia

X7 Research

Saint Petersburg, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 40638707 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35418437 (View on PubMed)

Other Identifiers

EFSA2020_03

Identifier Type: -

Identifier Source: org_study_id