MLC901 in Moderate Traumatic Brain Injury

Moderate Traumatic Brain Injury Clinical Trial

— ANDROMEDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766281
• Other study ID #: SJREB-2020-94
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: University of the Philippines
• Contact: Annabell E Chua, MD
• Phone: +632-85242338
• Email: aechua[@]up.edu.ph
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Moderate Traumatic Brain Injury

Intervention

Dietary Supplement:
• MLC901
This consists of extracts from 9 herbal components in a dark blue/light blue capsule

Genetic:
• Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule

Locations

Country	Name	City	State
Philippines	Mariano Marcos Memorial Hospital and Medical Center	Batac	Ilocos Norte
Philippines	Northern Mindanao Medical Center	Cagayan De Oro	Misamis Oriental
Philippines	Philippine General Hospital	Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality at 6 months	The number of patients who died in each arm at 6 months	18 months
Secondary	Cerebral swelling at baseline, 1 & 2 weeks	Cerebral swelling is assessed by CT-scan	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety until 9 months: adverse events	Safety is assessed by checking for the occurence of adverse events	18 months
Secondary	Compliance until 6 months	Compliance is documented by the number of medications taken at set intervals during follow up	18 months