NCT06731868

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tardive Dyskinesia (TD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-14
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2024-12-12
• Last updated: 2025-01-22

Locations

1 site across 1 country: China