MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Treatments: Drug: MLC 901; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05621590

IR.SBMU.RETECH.REC.1400.510

Details and patient eligibility

About

In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months.

We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery

Enrollment: 35 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation.

Exclusion criteria

• pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

mlc-901 group

Experimental group

Treatment:

Drug: MLC 901

placebo group

Placebo Comparator group

Treatment:

Drug: Placebo