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

Moleac

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04861688

EFSA2020_03

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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*.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

182 participants in 2 patient groups, including a placebo group

NeuroAiD II™ (MLC901)

Active Comparator group

Description:

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

Treatment:

Combination Product: Traditional Chinese Medicine (NeuroAiD II™ (MLC901)

Placebo

Placebo Comparator group

Description:

Capsule 2 capsules orally, 3 times a day

Treatment:

Other: Placebo