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

NCT04487275 | Unknown Phase 4

• 1 other identifier: 23-299
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (6)

• functional outcome 1

  functional outcome scales of GOS

  at baseline

• functional outcome 2

  functional outcome scales of GOS

  at 3rd month post-injury

• functional outcome 3

  functional outcome scales of GOS

  at 6th month post-injury

• functional outcome 4

  functional outcome scales of MRS

  at baseline

• functional outcome 5

  functional outcome scales of MRS

  at 3rd month post-injury

• functional outcome 6

  functional outcome scales of MRS

  at 6th month post-injury

Study Arms (2)

Drug

EXPERIMENTAL

MLC901 capsules three times per day over 6 months

Drug: MLC901 or Placebo

Placebo

PLACEBO COMPARATOR

Placebo capsules three times per day over 6 months

Drug: MLC901 or Placebo

Interventions

MLC901 or Placebo DRUG

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

Also known as: Placebo

Drug; Placebo

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Amini Harandi: lead

Study Sites (1)

Brain Mapping Research Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ali Amini Harandi, MD

CONTACT

+989126026214; amini_alli@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 27, 2020
• Study Start: August 20, 2018
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

IR (1)