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

Phase 4

• Conditions: Traumatic Brain Injury
• Interventions: Drug: MLC901 or Placebo

• Registration Number: NCT04487275
• Lead Sponsor: Ali Amini Harandi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-20
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27
• Primary Completion: 2020-09
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	MLC901 or Placebo	MLC901 capsules three times per day over 6 months
Placebo	MLC901 or Placebo	Placebo capsules three times per day over 6 months

Primary Outcome Measures

Name	Time	Method
functional outcome 5	at 3rd month post-injury	functional outcome scales of MRS
functional outcome 1	at baseline	functional outcome scales of GOS
functional outcome 2	at 3rd month post-injury	functional outcome scales of GOS
functional outcome 3	at 6th month post-injury	functional outcome scales of GOS
functional outcome 6	at 6th month post-injury	functional outcome scales of MRS
functional outcome 4	at baseline	functional outcome scales of MRS

Trial Locations

Locations (1)

Brain Mapping Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of