MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2020-10-31

Brief Summary

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Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Drug

MLC901 capsules three times per day over 6 months

Group Type EXPERIMENTAL

MLC901 or Placebo

Intervention Type DRUG

groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months

Placebo

Placebo capsules three times per day over 6 months

Group Type PLACEBO_COMPARATOR

MLC901 or Placebo

Intervention Type DRUG

groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months

Interventions

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MLC901 or Placebo

groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* age between 15 and 65
* non-penetrating moderate (Glasgow Coma Scale score \[GCS\] 9-12) or severe (GCS 3-8) traumatic brain
* injury less than 24 hrs from traumatic injury
* anticipated intensive care unit length of stay at least 48 hrs

Exclusion Criteria

* GCS = 3 and fixed dilated pupils or penetrating injury
* coexisting injury or medical conditions which could adversely affect our study outcome measures
* dependence for everyday activities before the injury
* pregnancy or breastfeeding
* known allergy to any of MLC901 components

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No