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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04487275

Acronym

MLC901

Enrollment

Registered

2020-07-27

Start date

2018-08-20

Completion date

2020-10-31

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

DRUGMLC901 or Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Iran

Contacts

Primary ContactAli Amini Harandi, MD

amini_alli@yahoo.com+989126026214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026