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

Early Phase 1

Completed

• Conditions: Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest
• Interventions: Drug: MLC 901; Drug: Placebo

• Registration Number: NCT05621590
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Status Verified: 2022-11
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mlc-901 group	MLC 901	-
placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
neurofunctional outcome using Glasgow Outcome Scale (GOS)	6 months
neurofunctional outcome using modified Rankin Scale (mRS)	6 months

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of