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

July 22, 2020 updated by: Ali Amini Harandi

MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug
MLC901 capsules three times per day over 6 months
Drug: MLC901 or Placebo
groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
Other Names:
  • Placebo
Placebo Comparator: Placebo
Placebo capsules three times per day over 6 months
Drug: MLC901 or Placebo
groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional outcome 1
Time Frame: at baseline
functional outcome scales of GOS
at baseline
functional outcome 2
Time Frame: at 3rd month post-injury
functional outcome scales of GOS
at 3rd month post-injury
functional outcome 3
Time Frame: at 6th month post-injury
functional outcome scales of GOS
at 6th month post-injury
functional outcome 4
Time Frame: at baseline
functional outcome scales of MRS
at baseline
functional outcome 5
Time Frame: at 3rd month post-injury
functional outcome scales of MRS
at 3rd month post-injury
functional outcome 6
Time Frame: at 6th month post-injury
functional outcome scales of MRS
at 6th month post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Amini Harandi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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