Actively Recruiting
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
Led by Luye Pharma Group Ltd. · Updated on 2025-01-22
120
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to less than 65 years
- Body mass index between 18.5 and 38.0 kg/m2
- Stable diagnosis of schizophrenia, schizoaffective disorder, bipolar or related disorders, or depressive disorders for at least 1 month
- Diagnosed with medication-induced tardive dyskinesia lasting at least 3 months with moderate or severe symptoms (AIMS Item 8 score 63;3)
- Stable doses of medications for psychiatric disorders and extrapyramidal symptoms for at least 1 month (benzodiazepines stable at least 14 days; long-acting injections stable at least 3 months)
- Females of childbearing potential must have a negative pregnancy test and both male and female patients and their partners must agree to use effective contraception during the study and for 1 month after last dose
You will not qualify if you...
- Presence of other abnormal involuntary movements more prominent than tardive dyskinesia
- Simpson-Angus Scale score 63;3 on two or more items except items 8 and 10
- Acute mental disorder phase or severe psychiatric symptoms interfering with cooperation
- History of suicide attempt or positive Columbia-Suicide Severity Rating Scale questions 4 or 5 within past 6 months
- History of neuroleptic malignant syndrome
- Diagnosis of malignant tumor within 3 years before enrollment
- History of long QT syndrome or tachyarrhythmia within 3 years before enrollment
- Electrocardiogram QTcF > 450 ms or other significant ECG abnormalities
- Significant abnormal liver or kidney function (serum creatinine >1.5x ULN; ALT or AST >2.5x ULN; total bilirubin >1.5x ULN)
- Active, severe, or unstable cerebrovascular, liver, kidney, endocrine, cardiovascular, gastrointestinal, respiratory, or metabolic disorders within 30 days before screening
- Surgical or medical conditions that may affect drug absorption or pose hazards, including gastrointestinal surgery or urinary tract issues
- Known allergy to study drug components or similar drugs
- Positive HIV antibody or syphilis test
- Positive urine drug screen
- Substance-related or addictive disorders (except tobacco or caffeine) within 6 months before screening
- Participation in drug clinical trials (excluding vitamins/minerals) within 3 months before screening
- Prior deep brain stimulation or electroconvulsive/physical therapy within 1 month before screening
- Use of strong CYP3A4 inducers or inhibitors within 14 days or 5 half-lives before enrollment
- History of nonresponse to tetrabenazine, deutetrabenazine, or valbenazine for tardive dyskinesia
- Botulinum toxin injection within past 3 months
- Use of prohibited drugs within past 1 month
- Nursing mothers
- For schizophrenia or schizoaffective disorder, total PANSS score > 80 or CDSS score > 10
- For bipolar or depressive disorders, history of rapid cycling or MADRS score > 22 or YMRS score > 12
- Any other condition judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, China
Actively Recruiting
Research Team
H
Hufang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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