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

NCT06731868 | Recruiting Phase 1

• 1 other identifier: LY03015/CT-CHN-204
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse event

  Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.

  From baseline to Week 8

• Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score

  Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

  From baseline to Week 8

Secondary Outcomes (6)

• The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score

  From baseline to Week 8

• Clinical Global Impression - Global Improvement of TD (CGI-TD)

  From Week 2 to Week 8

• Patient Global Impression of Change (PGIC)

  From Week 2 to Week 8

• Maximum observed concentration (Cmax)

  From predose to 24 hours of day 1

• Area Under the Curve from time 0 to 24 hours of day 1 (AUC0-24h)

  From predose to 24 hours of day 1

Study Arms (4)

LPM3770164 sustained release tablet 5 mg

EXPERIMENTAL

Drug: LPM3770164 sustained release tablet 5 mg

LPM3770164 sustained release tablet 10 mg

EXPERIMENTAL

Drug: LPM3770164 sustained release tablet 10 mg

LPM3770164 sustained release tablet 20 mg

EXPERIMENTAL

Drug: LPM3770164 sustained release tablet 20 mg

Placebo

PLACEBO COMPARATOR

Drug: LPM3770164 sustained release tablet simulant

Interventions

LPM3770164 sustained release tablet 5 mg DRUG

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

Also known as: LY03015

LPM3770164 sustained release tablet 5 mg

LPM3770164 sustained release tablet 10 mg DRUG

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

Also known as: LY03015

LPM3770164 sustained release tablet 10 mg

LPM3770164 sustained release tablet 20 mg DRUG

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

Also known as: LY03015

LPM3770164 sustained release tablet 20 mg

LPM3770164 sustained release tablet simulant DRUG

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

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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);
• 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);
• 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.

You may not qualify if:

• 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;
• Has a history of neuroleptic-related malignant syndrome;
• Has diagnosed with malignant tumor within 3 years before randomization;
• Has a history of long QT syndrome or tachyarrhythmia within 3 years before randomization;
• Electrocardiogram QTcF \> 450 ms, or other clinically significant ECG findings in the opinion of the investigator;
• 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;
• 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;
• 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;
• Has a known history of allergy to any component of the investigational product or similar drugs, or allergic constitution;
• Has a positive human immunodeficiency virus antibody (HIV-Ab) and syphilis;
• Has a positive urine drug screen;
• Patients diagnosed with substance-related and addictive disorders (except tobacco- or caffeine-related disorders) within 6 months prior to the screening visit;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hufang Li

CONTACT

+8618017311256; lhlh_5@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 14, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)