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Tests treatment safety and results for Tardive Dyskinesia (TD)
Official title Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
ClinicalTrials.gov ID: NCT06731868
What this study is testing
What is LPM3770164 sustained release tablet 5 mg?
LPM3770164 sustained release tablet 5 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tardive dyskinesia (td).
Also referred to as LY03015.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Subject who voluntarily participate in and sign the informed consent form;
- Male or female people aged ≥ 18 years and \< 65 years;
- Body mass index (BMI) 18.5 \~ 38.0 kg/m2 (including boundary value);
- people with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical...
- people 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...
You likely can't join 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...
- 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;
See the full eligibility criteria
- Subject who voluntarily participate in and sign the informed consent form;
- Male or female people aged ≥ 18 years and \< 65 years;
- Body mass index (BMI) 18.5 \~ 38.0 kg/m2 (including boundary value);
- people 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;
- people 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...
- 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...
- 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...
- 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...
- 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 people participating in the trial, such as but not...
- 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;
- Has participated in any clinical trials of drugs (excluding vitamins and minerals) within 3 months prior to the screening visit;
- 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;
- Patients who use of strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives, whichever is longer, prior to randomization;
- Known history of a nonresponder to tetrabenazine, deutetrabenazinen, or valbenazine for the treatment of TD;
- Patients who have been injected with botulinum toxin in the past 3 months;
- Patients who have used the prohibited drugs in the past 1 month;
- Nursing mothers;
- For patients with schizophrenia and schizoaffective disorder, has a total PANSS score \> 80, and/or a total CDSS score \> 10;
- 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;
- Other conditions judged by the investigator as unsuitable for participating in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.