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 range18 Years – 64 Years
SexALL
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
✕. 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;
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
. 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;