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

Ali Amini Harandi

Status and phase: Unknown; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Drug: MLC901 or Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04487275

23-299

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Description:

MLC901 capsules three times per day over 6 months

Treatment:

Drug: MLC901 or Placebo

Placebo

Placebo Comparator group

Description:

Placebo capsules three times per day over 6 months

Treatment:

Drug: MLC901 or Placebo