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

NCT04487275 — Phase 4, Unknown, 80 participants, Ali Amini Harandi

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

Registry	NCT04487275, acronym MLC901
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	80 (Estimated)
Sponsor	Ali Amini Harandi (Other)
Conditions	Traumatic Brain Injury
Interventions	MLC901 or Placebo (Drug)
Dates	start 2018-08-20, primary completion 2020-09-01 (estimated), completion 2020-10-01 (estimated), first posted 2020-07-27, last updated 2020-07-27
Locations	1 site in Iran

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Drug	Experimental	Drug: MLC901 or Placebo	MLC901 capsules three times per day over 6 months
Placebo	Placebo comparator	Drug: MLC901 or Placebo	Placebo capsules three times per day over 6 months

MLC901 or Placebo (Drug), also known as Placebo: groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 15 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Brain Mapping Research Center	Tehran	Iran	Recruiting