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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPM3770164 sustained release tablet 5 mg | Experimental |
| |
| LPM3770164 sustained release tablet 10 mg | Experimental |
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| LPM3770164 sustained release tablet 20 mg | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3770164 sustained release tablet 5 mg | Drug | LPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score | From baseline to Week 8 | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | From Week 2 to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hufang Li | Contact | +8618017311256 | lhlh_5@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | China |
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| LPM3770164 sustained release tablet 10 mg | Drug | LPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks. |
|
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| LPM3770164 sustained release tablet 20 mg | Drug | LPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks. |
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| LPM3770164 sustained release tablet simulant | Drug | LPM3770164 sustained release tablet simulant once daily oral for 6 weeks. |
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| Patient Global Impression of Change (PGIC) | From Week 2 to Week 8 |
| Maximum observed concentration (Cmax) | From predose to 24 hours of day 1 |
| Area Under the Curve from time 0 to 24 hours of day 1 (AUC0-24h) | From predose to 24 hours of day 1 |
| Concentration at the end of the dosing interval at steady state (Cτ,ss) | Predose on Day 14±2, Day 28±2 and Day 42±2 |
| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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