Clinical trial NCT04861688: NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Randomized Double-blind
Placebo-controlled
NeuroAiD II™
MLC901
Traditional Chinese Medicine
Cognitive Functioning
Lead sponsor: Moleac Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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\*.

Primary outcomes:
measure: Central Nervous System Vital Signs (CNS-VS), Domain score: Complex Attention
timeFrame: 6 months of treatment compared to baseline
Secondary outcomes:
measure: CNS-VS system, Domain score: Execution Function
timeFrame: after 6 months of treatment compared to baseline
measure: CNS-VS system, Domain score: Processing speed
timeFrame: after 6 months of treatment, compared to baseline
measure: CNS-VS system, Domain score: Visual memory
timeFrame: after 6 months of treatment, compared to baseline
measure: CNS-VS system, Domain score: Verbal memory
timeFrame: after 6 months of treatment, compared to baseline
measure: CNS-VS system, Domain score: Reaction time
timeFrame: after 6 months of treatment, compared to baseline
measure: Rivermead Post Concussion Symptoms Questionnaire (RPQ)
timeFrame: after 6 months of treatment, compared to baseline
Other outcomes:
Locations:
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod regional clinical hospital named after N. A. Semashko
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Municipal Polyclinic № 106 of St.Petersburg
city: St.Petersburg
country: Russian Federation
facility: X7 Research
Study officials:
References:
citation: 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.