Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia (NCT06731868) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
China120 participantsStarted 2025-01-14
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-emergent adverse event
Timeframe: From baseline to Week 8
2
Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
. 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;