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

NCT ID: NCT06731868

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-10-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LPM3770164 sustained release tablet 5 mg

Group Type: EXPERIMENTAL

LPM3770164 sustained release tablet 5 mg

Intervention Type: DRUG

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

LPM3770164 sustained release tablet 10 mg

Group Type: EXPERIMENTAL

LPM3770164 sustained release tablet 10 mg

Intervention Type: DRUG

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

LPM3770164 sustained release tablet 20 mg

Group Type: EXPERIMENTAL

LPM3770164 sustained release tablet 20 mg

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

LPM3770164 sustained release tablet simulant

Intervention Type: DRUG

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

Interventions

LPM3770164 sustained release tablet 5 mg

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

Intervention Type: DRUG

LPM3770164 sustained release tablet 10 mg

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

Intervention Type: DRUG

LPM3770164 sustained release tablet 20 mg

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

Intervention Type: DRUG

LPM3770164 sustained release tablet simulant

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

Intervention Type: DRUG

Other Intervention Names

LY03015; LY03015; LY03015; placebo

Eligibility Criteria

Inclusion Criteria

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

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

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

4. 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;

5. Subjects who have been diagnosed with medication-induced TD, and whose symptoms have lasted for at least 3 months according to the DSM-5; and TD is assessed as moderate or severe (AIMS Item 8 score ≥3);

6. Medications for schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders and extrapyramidal reactions should be kept dose stable for at least 1 month (benzodiazepines should stable at least 14 days, Long-acting injection should stable for at least 3 months);

7. Females of childbearing potential have a negative pregnancy test. Male and female patients of childbearing potential and their spouses/partners agree to not plan to become pregnant (including the plan for sperm and egg donation) and to use effective contraceptive measures throughout the study and for at least 1 month after the last dose of the study drug.

Exclusion Criteria

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

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

3. 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;

4. 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;

5. Has a history of neuroleptic-related malignant syndrome;

6. Has diagnosed with malignant tumor within 3 years before randomization;

7. Has a history of long QT syndrome or tachyarrhythmia within 3 years before randomization;

8. Electrocardiogram QTcF > 450 ms, or other clinically significant ECG findings in the opinion of the investigator;

9. Patients with significant abnormal liver and kidney function indicators, meeting any of the following criteria: serum creatinine > 1.5 × upper limit of normal (ULN); serum alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 × ULN; total bilirubin > 1.5 × ULN;

10. Has active, severe and unstable cerebrovascular, liver, kidney, endocrine, cardiovascular, gastrointestinal, respiratory, or metabolic disorders within 30 days prior to screening, in the judgment of the investigator, would interfere with the patient's ability to participate in the trial;

11. Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as but not limited to history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding;

12. Has a known history of allergy to any component of the investigational product or similar drugs, or allergic constitution;

13. Has a positive human immunodeficiency virus antibody (HIV-Ab) and syphilis;

14. Has a positive urine drug screen;

15. Patients diagnosed with substance-related and addictive disorders (except tobacco- or caffeine-related disorders) within 6 months prior to the screening visit;

16. Has participated in any clinical trials of drugs (excluding vitamins and minerals) within 3 months prior to the screening visit;

17. Patients who previously received deep brain stimulation (DBS), or received electroconvulsive therapy (ECT) or other physical therapy within 1 month prior to the screening visit;

18. Patients who use of strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives, whichever is longer, prior to randomization;

19. Known history of a nonresponder to tetrabenazine, deutetrabenazinen, or valbenazine for the treatment of TD;

20. Patients who have been injected with botulinum toxin in the past 3 months;

21. Patients who have used the prohibited drugs in the past 1 month;

22. Nursing mothers;

23. For patients with schizophrenia and schizoaffective disorder, has a total PANSS score > 80, and/or a total CDSS score > 10;

24. For patients with bipolar and related disorders or depressive disorders, has a history of rapid cycling, or a total MADRS score > 22, or a total YMRS score > 12;

25. Other conditions judged by the investigator as unsuitable for participating in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hufang Li

Role: CONTACT

lhlh_5@163.com

+8618017311256

Facility Contacts

Huafang Li

Role: primary

lhlh_5@163.com

+8618017311256

Other Identifiers

LY03015/CT-CHN-204

Identifier Type: -

Identifier Source: org_study_id