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

StatusRecruiting
PhasePhase 1/2
Started2025-01-14
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 22, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-01-20
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-31→confirmed 2025-01-14
Primary endpoints2 entries, revised
ImprovementChange in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Study sitesdetails revised at 1 of 1 site
2024-12-11
Original filing
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.
Trial Details
NCT Number NCT06731868
Lead Sponsor Luye Pharma Group Ltd.
Conditions Tardive Dyskinesia (TD)
Enrollment 120 participants
Start Date 2025-01-14
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-22