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

NCT04487275 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MLC901 or Placebo

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

Sponsors & Collaborators

  • Ali Amini Harandi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2020-09-30
Completion
2020-10-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04487275 on ClinicalTrials.gov