Back to resultsMLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code) (MLC901)
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
MLC901 or Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility 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
Sites / Locations
- Brain Mapping Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug
Placebo
Arm Description
MLC901 capsules three times per day over 6 months
Placebo capsules three times per day over 6 months
Outcomes
Primary Outcome Measures
functional outcome 1
functional outcome scales of GOS
functional outcome 2
functional outcome scales of GOS
functional outcome 3
functional outcome scales of GOS
functional outcome 4
functional outcome scales of MRS
functional outcome 5
functional outcome scales of MRS
functional outcome 6
functional outcome scales of MRS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04487275
Brief Title
MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)
Acronym
MLC901
Official Title
MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Amini Harandi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Arm Description
MLC901 capsules three times per day over 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules three times per day over 6 months
Intervention Type
Drug
Intervention Name(s)
MLC901 or Placebo
Other Intervention Name(s)
Placebo
Intervention Description
groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
Primary Outcome Measure Information:
Title
functional outcome 1
Description
functional outcome scales of GOS
Time Frame
at baseline
Title
functional outcome 2
Description
functional outcome scales of GOS
Time Frame
at 3rd month post-injury
Title
functional outcome 3
Description
functional outcome scales of GOS
Time Frame
at 6th month post-injury
Title
functional outcome 4
Description
functional outcome scales of MRS
Time Frame
at baseline
Title
functional outcome 5
Description
functional outcome scales of MRS
Time Frame
at 3rd month post-injury
Title
functional outcome 6
Description
functional outcome scales of MRS
Time Frame
at 6th month post-injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Amini Harandi, MD
Phone
+989126026214
Email
amini_alli@yahoo.com
Facility Information:
Facility Name
Brain Mapping Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Amini Harandi, MD
Phone
+989126026214
Email
amini_alli@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)
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