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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04487275
Other study ID # 23-299
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 20, 2018
Est. completion date October 2020

Study information

Verified date July 2020
Source Shahid Beheshti University
Contact Ali Amini Harandi, MD
Phone +989126026214
Email amini_alli@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Iran, Islamic Republic of Brain Mapping Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
Ali Amini Harandi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary functional outcome 1 functional outcome scales of GOS at baseline
Primary functional outcome 2 functional outcome scales of GOS at 3rd month post-injury
Primary functional outcome 3 functional outcome scales of GOS at 6th month post-injury
Primary functional outcome 4 functional outcome scales of MRS at baseline
Primary functional outcome 5 functional outcome scales of MRS at 3rd month post-injury
Primary functional outcome 6 functional outcome scales of MRS at 6th month post-injury
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