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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487275
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Amini Harandi, Shahid Beheshti University

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: MLC901 or Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. functional outcome 1 [ Time Frame: at baseline ]
    functional outcome scales of GOS

  2. functional outcome 2 [ Time Frame: at 3rd month post-injury ]
    functional outcome scales of GOS

  3. functional outcome 3 [ Time Frame: at 6th month post-injury ]
    functional outcome scales of GOS

  4. functional outcome 4 [ Time Frame: at baseline ]
    functional outcome scales of MRS

  5. functional outcome 5 [ Time Frame: at 3rd month post-injury ]
    functional outcome scales of MRS

  6. functional outcome 6 [ Time Frame: at 6th month post-injury ]
    functional outcome scales of MRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487275


Contacts
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Contact: Ali Amini Harandi, MD +989126026214 amini_alli@yahoo.com

Locations
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Iran, Islamic Republic of
Brain Mapping Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Ali Amini Harandi, MD    +989126026214    amini_alli@yahoo.com   
Sponsors and Collaborators
Ali Amini Harandi
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Responsible Party: Ali Amini Harandi, Prof, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT04487275    
Other Study ID Numbers: 23-299
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System