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RECRUITING
NCT06731868
PHASE1/PHASE2

Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

Sponsor: Luye Pharma Group Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-01-14

Completion Date

2025-10-31

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

DRUG

LPM3770164 sustained release tablet 5 mg

LPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks

DRUG

LPM3770164 sustained release tablet 10 mg

LPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks.

DRUG

LPM3770164 sustained release tablet 20 mg

LPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks.

DRUG

LPM3770164 sustained release tablet simulant

LPM3770164 sustained release tablet simulant once daily oral for 6 weeks.

Locations (1)

Shanghai Mental Health Center

Shanghai, China