MLC901 in Moderate Traumatic Brain Injury (ANDROMEDA)

University of the Philippines

Status and phase: Enrolling; Phase 4

Conditions: Moderate Traumatic Brain Injury

Treatments: Dietary Supplement: MLC901; Genetic: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04766281

SJREB-2020-94

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

MLC901 (NeuroAiD II)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: MLC901

Placebo

Placebo Comparator group

Description:

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

Treatment:

Genetic: Placebo