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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorLuye Pharma Group Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Subject who voluntarily participate in and sign the informed consent form;

Male or female subjects aged ≥ 18 years and < 65 years;

Body mass index (BMI) 18.5 ~ 38.0 kg/m2 (including boundary value);

Subjects with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical history, and stable for at least 1 month;

Disqualifiers

Has comorbid abnormal involuntary movement(s) that is more prominent than TD as judged by the investigator;

Has Simpson-Angus Scale (SAS) score≥ 3 on two or more items other than items 8 and 10;

Currently in the acute phase of mental disorder or severe psychiatric symptoms, unable to cooperate with the treatment and assessment, as judged by the investigator;

Has a history of suicide attempt or Question 4 or Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as "Yes" within the past 6 months;

Trial design

Treatments tested in this trial

  • LPM3770164 sustained release tablet 5 mg
  • LPM3770164 sustained release tablet 10 mg
  • LPM3770164 sustained release tablet 20 mg
  • LPM3770164 sustained release tablet simulant

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators