Actively Recruiting
Study of LPM3770164 Sustained-release Tablets to Evaluate Safety, Tolerability, and Early Effects 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
Researchers are evaluating the safety, tolerability, preliminary effectiveness, and pharmacokinetic properties of different doses of LPM3770164 sustained-release tablets in patients with tardive dyskinesia (TD). This multicenter, randomized, double-blind, placebo-controlled trial includes adults aged 18 to under 65 who have stable psychiatric conditions such as schizophrenia or bipolar disorder and have moderate to severe TD symptoms lasting at least 3 months. Participants are assigned to receive one of the following once-daily oral treatments for 6 weeks: LPM3770164 at doses of 5 mg, 10 mg, or 20 mg, or a placebo tablet designed to simulate the study drug. The study monitors multiple doses to assess safety and how the drug is processed in the body. During the study, participants will be regularly assessed for treatment-emergent side effects and changes in involuntary movement severity using the Abnormal Involuntary Movement Scale (AIMS). Monitoring includes clinical evaluations for adverse events and movement changes from baseline through Week 8, ensuring patient safety and detailed tracking of treatment effects over time.
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
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Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, China
Actively Recruiting
Research Team
H
Hufang Li
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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