MLC901 in Moderate Traumatic Brain Injury

NCT04766281 | Unknown Phase 4

• 1 other identifier: SJREB-2020-94
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Moderate Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Mortality at 6 months

  18 months

• Cerebral swelling at baseline, 1 & 2 weeks

  18 months

• Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months

  18 months

• Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months

  18 months

• Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months

  18 months

Study Arms (2)

MLC901 (NeuroAiD II)

ACTIVE COMPARATOR

This consists of extracts from 9 herbal components in a dark blue/light blue capsule

Dietary Supplement: MLC901

Placebo

PLACEBO COMPARATOR

This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule

Genetic: Placebo

Interventions

MLC901 DIETARY_SUPPLEMENT

This consists of extracts from 9 herbal components in a dark blue/light blue capsule

Also known as: NeuroAiD II

MLC901 (NeuroAiD II)

Placebo GENETIC

This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (3)

Mariano Marcos Memorial Hospital and Medical Center

Batac, Ilocos Norte, Philippines

RECRUITING

Northern Mindanao Medical Center

Cagayan de Oro, Misamis Oriental, 9000, Philippines

RECRUITING

Philippine General Hospital

Manila, 1000, Philippines

RECRUITING

Related Publications (1)

• Chua AE, Yacapin VJ, Manalo GL 3rd, Ledesma LK. Protocol for Safety and Efficacy of MLC901 (NeuroAiD II) in Patients With Moderate Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Trial (ANDROMEDA). Neurosurgery. 2023 Oct 1;93(4):939-951. doi: 10.1227/neu.0000000000002512. Epub 2023 May 2.

  PMID: 37129384 DERIVED

MeSH Terms

Interventions

Neuroaid

Study Officials

• Annabell E Chua, MD

  University of the Philippines Manila - Philippine General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabell E Chua, MD

CONTACT

+632-85242338; aechua@up.edu.ph

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to receive either MLC901 or placebo

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 23, 2021
• Study Start: May 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: July 31, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

PH (3)