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NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury (SAMURAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04861688
Recruitment Status : Completed
First Posted : April 27, 2021
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Moleac Pte Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901) Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 23, 2021
Actual Primary Completion Date : February 14, 2023
Actual Study Completion Date : February 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NeuroAiD II™ (MLC901)
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)
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 Comparator: Placebo
Capsule 2 capsules orally, 3 times a day
 Other: Placebo
Placebo with same appearance as active intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. CNS-VS system, Domain score: Execution Function [ Time Frame: after 6 months of treatment compared to baseline ]

    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.


  2. CNS-VS system, Domain score: Processing speed [ Time Frame: after 6 months of treatment, compared to baseline ]

    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.


  3. CNS-VS system, Domain score: Visual memory [ Time Frame: after 6 months of treatment, compared to baseline ]

    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.


  4. CNS-VS system, Domain score: Verbal memory [ Time Frame: after 6 months of treatment, compared to baseline ]

    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.


  5. CNS-VS system, Domain score: Reaction time [ Time Frame: after 6 months of treatment, compared to baseline ]

    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.


  6. Rivermead Post Concussion Symptoms Questionnaire (RPQ) [ Time Frame: after 6 months of treatment, compared to baseline ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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*.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861688


Locations
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Russian Federation
Nizhny Novgorod regional clinical hospital named after N. A. Semashko
Nizhny Novgorod, Russian Federation, 603126
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation
Municipal Polyclinic № 106 of St.Petersburg
Saint Petersburg, Russian Federation
X7 Research
St.Petersburg, Russian Federation
Sponsors and Collaborators
Moleac Pte Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Moleac Pte Ltd.
ClinicalTrials.gov Identifier: NCT04861688    
Other Study ID Numbers: EFSA2020_03
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moleac Pte Ltd.:
Traumatic Brain Injury
Randomized Double-blind
Placebo-controlled
NeuroAiD II™
 MLC901
Traditional Chinese Medicine
Cognitive Functioning
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating