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

Traumatic Brain Injury Clinical Trial

— MLC901  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487275
• Other study ID #: 23-299
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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