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MLC1501 Study Assessing Efficacy in STROke Recovery

NCT05046106 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-03-16

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.

Conditions

  • Stroke
  • Stroke, Ischemic
  • Strokes Thrombotic
  • Stroke Sequelae
  • Stroke, Cardiovascular
  • Stroke, Embolic
  • Stroke, Cryptogenic

Interventions

DRUG

MLC1501

Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

OTHER

Placebo

Caramel, chocolate brown, flavor (E\_1982648), dextrin

Sponsors & Collaborators

  • Moleac Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Christopher Chen, BMBCh, MRCP, FAMS, FRCPE · Departments of Pharmacology and Psychological Medicine, National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2028-09-30
Completion
2028-12-31
FDA Drug
Yes

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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 NCT05046106 on ClinicalTrials.gov