Traumatic Brain InjuryPhase 3SAMURAINCT04861688
NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
A Phase 3 study testing Traditional Chinese Medicine (NeuroAiD II™ (MLC901) in people with Traumatic Brain Injury, run by Moleac Pte Ltd. at 4 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Traditional Chinese Medicine (NeuroAiD II™ (MLC901)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 4 sitesRussia
- Study dates
- 23 Aug 2021to 14 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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*.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Nizhny Novgorod regional clinical hospital named after N. A. Semashko
Nizhny Novgorod, 603126
State Novosibirsk Regional Clinical Hospital
Novosibirsk
Municipal Polyclinic № 106 of St.Petersburg
Saint Petersburg
X7 Research
Saint Petersburg
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II™ (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients
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
- Being tested
- Traditional Chinese Medicine (NeuroAiD II™ (MLC901), Placebo
- Keywords
- Traumatic Brain Injury, Randomized Double-blind, Placebo-controlled, NeuroAiD II™, MLC901, Traditional Chinese Medicine, Cognitive Functioning
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Placebo with same appearance as active intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901) |
| Placebo | Placebo comparator | Capsule 2 capsules orally, 3 times a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months of treatment compared to baseline
Secondary outcomes (6)
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.
Measured: after 6 months of treatment compared to baseline
CNS-VS system, Domain score: Processing speed
Changes in the scores for the following cognitive domains: processing speed, 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.
Measured: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Visual memory
Changes in the scores for the following cognitive domains: visual memory, 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.
Measured: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Verbal memory
Changes in the scores for the following cognitive domains: verbal memory, 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.
Measured: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Reaction time
Changes in the scores for the following cognitive domains: reaction time, 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.Lower score is better.
Measured: after 6 months of treatment, compared to baseline
Rivermead Post Concussion Symptoms Questionnaire (RPQ)
Change in the Rivermead Post Concussion Symptoms Questionnaire (RPQ) total score, after 6 months of treatment, compared to baseline, in the NeuroAiD II™ (MLC901) group compared to the placebo group.
Scoring system is in two groups. RPQ-3 is potentially 0-12 and a higher score is worse, requires closer monitoring. RPQ-13 score is potentially 0-52 where higher scores reflect greater severity.
Measured: after 6 months of treatment, compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Aug 2021
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861688
- Sponsor's protocol ID
- EFSA2020_03
- Acronym
- SAMURAI
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40638707Pilipenko 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.
PubMed 35418437
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II™ (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT04861688
- Acronym / sponsor ID
- SAMURAI / EFSA2020_03
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Randomized Double-blind, Placebo-controlled, NeuroAiD II™, MLC901, Traditional Chinese Medicine, Cognitive Functioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroAiD II™ (MLC901) | Active comparator | Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901)Recommended treatment is 2 capsules orally, 3 times a day (i.e. 6 capsules per day). Treatment is 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboCapsule 2 capsules orally, 3 times a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | NeuroAiD II™ (MLC901) |
| PlaceboPlacebo with same appearance as active intervention | Other | Placebo |
Primary outcome
Central Nervous System Vital Signs (CNS-VS), Domain score: Complex Attention
Time frame: 6 months of treatment compared to baseline
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 secondary outcomes
CNS-VS system, Domain score: Execution Function
Time frame: after 6 months of treatment compared to baseline
CNS-VS system, Domain score: Processing speed
Time frame: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Visual memory
Time frame: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Verbal memory
Time frame: after 6 months of treatment, compared to baseline
CNS-VS system, Domain score: Reaction time
Time frame: after 6 months of treatment, compared to baseline
Rivermead Post Concussion Symptoms Questionnaire (RPQ)
Time frame: after 6 months of treatment, compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 40638707Pilipenko 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.
- Derived from this study: PubMed 35418437Pilipenko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine (NeuroAiD II™ (MLC901) in people with Traumatic Brain Injury, run by Moleac Pte Ltd. at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Nervous System Vital Signs (CNS-VS), Domain score: Complex Attention (time frame: 6 months of treatment compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861688, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.