MLC901 in Hypoxic-ischemic Brain Injury Patients; A Doubl... | NCT05621590

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

NCT05621590

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Nov 18, 2022Actual

Enrollment

35Actual

Phase

Early Phase 1

Conditions

Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Interventions

MLC 901
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2020Actual

Primary Completion Date

Aug 12, 2022Actual

Completion Date

Aug 12, 2022Actual

First Submitted Date

Nov 11, 2022

First Submission Date that Met QC Criteria

Nov 17, 2022

First Posted Date

Nov 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2022

Last Update Posted Date

Nov 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ali Amini Harandi, associate professor, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mlc-901 group	Experimental		Drug: MLC 901
placebo group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MLC 901	Drug	MLC901, also known as NeuroAiDII, is a capsule form of drug which should be taken orally and combines nine herbal components	mlc-901 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neurofunctional outcome using Glasgow Outcome Scale (GOS)		6 months
neurofunctional outcome using modified Rankin Scale (mRS)		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Beheshti University of Medical Sciences, Shohada Hospital		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29042785	Background	Pakdaman H, Amini Harandi A, Gharagozli K, Abbasi M, Ghaffarpour M, Ashrafi F, Delavar Kasmaei H, Amini Harandi A. MLC601 in vascular dementia: an efficacy and safety pilot study. Neuropsychiatr Dis Treat. 2017 Oct 5;13:2551-2557. doi: 10.2147/NDT.S145047. eCollection 2017.