Tardive Dyskinesia (TD)Phase 1/2NCT06731868
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
A Phase 1/2 study testing LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg and LPM3770164 sustained release tablet 20 mg in people with Tardive Dyskinesia (TD), run by Luye Pharma Group Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tardive Dyskinesia (TD)
- What is being tested?
- LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg and LPM3770164 sustained release tablet 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2025to 31 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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 transaminase (AST) > 2.5 × ULN; total bilirubin > 1.5 × ULN;
- 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, would interfere with the patient's ability to participate in the trial;
- 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 subjects participating in the trial, such as but not limited to history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Huafang Li, +8618017311256, lhlh_5@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
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
- Tardive Dyskinesia (TD)
- Being tested
- LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg, LPM3770164 sustained release tablet 20 mg, LPM3770164 sustained release tablet simulant
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM3770164 sustained release tablet 5 mgDrug
Also called LY03015
LPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks
LPM3770164 sustained release tablet 10 mgDrug
Also called LY03015
LPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks.
LPM3770164 sustained release tablet 20 mgDrug
Also called LY03015
LPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks.
LPM3770164 sustained release tablet simulantDrug
Also called placebo
LPM3770164 sustained release tablet simulant once daily oral for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LPM3770164 sustained release tablet 5 mg | Experimental | Not described Receives: Drug: LPM3770164 sustained release tablet 5 mg |
| LPM3770164 sustained release tablet 10 mg | Experimental | Not described Receives: Drug: LPM3770164 sustained release tablet 10 mg |
| LPM3770164 sustained release tablet 20 mg | Experimental | Not described Receives: Drug: LPM3770164 sustained release tablet 20 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: LPM3770164 sustained release tablet simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse event
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Measured: From baseline to Week 8
Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Measured: From baseline to Week 8
Secondary outcomes (6)
The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score
Measured: From baseline to Week 8
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Measured: From Week 2 to Week 8
Patient Global Impression of Change (PGIC)
Measured: From Week 2 to Week 8
Maximum observed concentration (Cmax)
Measured: From predose to 24 hours of day 1
Area Under the Curve from time 0 to 24 hours of day 1 (AUC0-24h)
Measured: From predose to 24 hours of day 1
Concentration at the end of the dosing interval at steady state (Cτ,ss)
Measured: Predose on Day 14±2, Day 28±2 and Day 42±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start14 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive Dyskinesia (TD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731868
- Sponsor's protocol ID
- LY03015/CT-CHN-204
- Status last verified
- Jan 2025
- First submitted
- 9 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
- ClinicalTrials.gov ID
- NCT06731868
- Acronym / sponsor ID
- LY03015/CT-CHN-204
- Conditions
- Tardive Dyskinesia (TD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LPM3770164 sustained release tablet 5 mg | Experimental | Drug: LPM3770164 sustained release tablet 5 mg |
| LPM3770164 sustained release tablet 10 mg | Experimental | Drug: LPM3770164 sustained release tablet 10 mg |
| LPM3770164 sustained release tablet 20 mg | Experimental | Drug: LPM3770164 sustained release tablet 20 mg |
| Placebo | Placebo comparator | Drug: LPM3770164 sustained release tablet simulant |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPM3770164 sustained release tablet 5 mgAlso: LY03015LPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks | Drug | LPM3770164 sustained release tablet 5 mg |
| LPM3770164 sustained release tablet 10 mgAlso: LY03015LPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks. | Drug | LPM3770164 sustained release tablet 10 mg |
| LPM3770164 sustained release tablet 20 mgAlso: LY03015LPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks. | Drug | LPM3770164 sustained release tablet 20 mg |
| LPM3770164 sustained release tablet simulantAlso: placeboLPM3770164 sustained release tablet simulant once daily oral for 6 weeks. | Drug | Placebo |
Primary outcome
Treatment-emergent adverse event
Time frame: From baseline to Week 8
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Time frame: From baseline to Week 8
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
6 secondary outcomes
The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score
Time frame: From baseline to Week 8
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Time frame: From Week 2 to Week 8
Patient Global Impression of Change (PGIC)
Time frame: From Week 2 to Week 8
Maximum observed concentration (Cmax)
Time frame: From predose to 24 hours of day 1
Area Under the Curve from time 0 to 24 hours of day 1 (AUC0-24h)
Time frame: From predose to 24 hours of day 1
Concentration at the end of the dosing interval at steady state (Cτ,ss)
Time frame: Predose on Day 14±2, Day 28±2 and Day 42±2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Related trials for Tardive Dyskinesia (TD)
RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg and LPM3770164 sustained release tablet 20 mg in people with Tardive Dyskinesia (TD), run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hufang Li (+8618017311256, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse event (time frame: From baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.