MLC901 in Moderate Traumatic Brain Injury (ANDROMEDA)

Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial

This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.

Study Overview

• Status: Recruiting
• Conditions: Moderate Traumatic Brain Injury
• Intervention / Treatment: Dietary supplement: MLC901; Genetic: Placebo

Detailed Description

This is a double blind placebo controlled randomized trial to determine whether giving MLC901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Annabell E Chua, MD; Phone Number: +632-85242338; Email: aechua@up.edu.ph

Study Locations

• Philippines
  • Manila, Philippines, 1000
    • Recruiting
    • Philippine General Hospital
    • Contact: Annabell E Chua, M.D.; Phone Number: 0285242338; Email: aechua@up.edu.ph
  • Ilocos Norte
    • Batac, Ilocos Norte, Philippines
      • Recruiting
      • Mariano Marcos Memorial Hospital and Medical Center
      • Contact: Tercy Manalo, M.D.; Email: terc81@yahoo.com
  • Misamis Oriental
    • Cagayan De Oro, Misamis Oriental, Philippines, 9000
      • Recruiting
      • Northern Mindanao Medical Center
      • Contact: Vilma Yacapin, M.D.; Email: Penfield100370@yahoo.com.ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years
• Moderate TBI
• Presenting at the study site within 7 days of injury
• Participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent

Exclusion Criteria:

• Penetrating HI
• Co-existing severe or unstable injury
• Physician's medical judgment that surgical intervention is likely within the next 48 hours
• Physician's medical judgment that participation is not in the participant's best interest
• Pre-injury mRS>2
• Pregnancy
• Inability to take study drug orally or via NGT
• Participation in another investigational drug study
• Intake of nootropic drugs which are not standard TBI medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MLC901 (NeuroAiD II); This consists of extracts from 9 herbal components in a dark blue/light blue capsule	Dietary supplement: MLC901; This consists of extracts from 9 herbal components in a dark blue/light blue capsule; Other Names: NeuroAiD II
Placebo Comparator: Placebo; This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule	Genetic: Placebo; This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GOS-E at 6 months	This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 6 months	The number of patients who died in each arm at 6 months	18 months
Cerebral swelling at baseline, 1 & 2 weeks	Cerebral swelling is assessed by CT-scan	18 months
Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months	This clinical scale is the most widely used outcome measure after TBI, with the extended version scoring from 0 (dead) to full recovery (8).	18 months
Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months	This is a widely used clinical scale to assess the depth and duration of impaired consciousness and coma by measuring motor responsiveness, verbal performance and eye opening. The score ranges from 3 to 15.	18 months
Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months	This is an adaptation of the MoCA to the Philippine setting, used in the detection of mild cognitive impairment. The scores range between 0-10, with a score of 26 or over considered to be normal.	18 months
Frontal Assessment Battery at 1,3,6 & 9 monts	This battery of tests is used to assess frontal lobe dysfunction, consisting of the following sub tests: conceptualisation, mental flexibility, motor programming, sensitivity to interference, inhibitory control and environmental autonomy.Total scor is from a maximum of 18, with higher scores indicating better performance.	18 months
RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months	This is a 10 item questionnaire mainly used for patients with mild to moderate TBI. This is a 16 item questionnaire, scored on a 5 point Liberty scale ranging from 0 (not experienced at all) to 4 ( a severe problem).	18 months
Barthel Index (BI) at 1,3,6 & 9 months	This scale is used to assess functional disability by quantifying patient performance in 10 activities of daily living. The score ranges from 0 (totally dependent) to 100 (fully independent).	18 months
Hospital Anxiety and Depression Scale at 1,3,6 & 9 months	This scale is used to measure levels of anxiety and depression, ranging from 0 to 21,with normal score of 0-7, mild 8-10, moderate 11-14 and severe 15-21.	18 months
EQ-5D at 1,3,6 & 9 months (EuroQol Group)	This instrument describes the health status of respondents in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from 0-100, with higher scores for higher health related quality of life.	18 months
Safety until 9 months: adverse events	Safety is assessed by checking for the occurence of adverse events	18 months
Compliance until 6 months	Compliance is documented by the number of medications taken at set intervals during follow up	18 months

Collaborators and Investigators

• Sponsor: University of the Philippines
• Investigators: Principal Investigator: Annabell E Chua, MD, University of the Philippines Manila - Philippine General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: SJREB-2020-94

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No