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Completed

NCT Number: NCT04861688

NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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*.

Treatment and study plan

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.

Placebo

Other

Placebo with same appearance as active intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Moleac Pte Ltd.

Industry

Registry information

Official study 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

Acronym: SAMURAI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2021
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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