Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia

Официальное название

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia

Обзор

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Подробное описание

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia

Вмешательства

• Препарат LB-102 (50 mg tablet)
  LB-102 oral tablet given for six weeks
• Препарат LB-102 (100 mg tablet)
  LB-102 oral tablet given for six weeks
• Другое Placebo
  Placebo tablet given orally for six weeks

Первичные конечные точки

• Change from baseline to Week 6 on the Positive and Negative Syndrome Scale [Срок оценки: 6 weeks]

Вторичные конечные точки (2)

• Evaluate the Safety and Tolerability of LB-102 [Срок оценки: 10 weeks]
• Change in Clinical Global Impressions-Severity of Illness scale (CGI-S) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Able to provide ICF
• Willing to be hospitalized for duration of the study
• Diagnosis of schizophrenia as defined by DSM-5
• BMI - 18-40
• PANSS 80-120

Критерии исключения

• Sexually active m/f not willing to adhere to highly effect birth control
• Breast feeding
• Increase in PANSS of > 20% between screening and baseline
• History of resistant treatment to schizophrenia medications
• DSM-5 diagnosis other than schizophrenia
• Risk of suicidal behavior
• Risk of violent or destructive behavior
• Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
• Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
• Insulin dependent diabetes
• Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• Pillar Clinical Research — Bentonville
• Pillar Clinical Research — Little Rock
• Woodland International Research Group — Little Rock
• ProScience Research Group — Culver City
• CenExel — Garden Grove
• Synergy San Diego — Lemon Grove
• Clinical Innovations, Inc. — Riverside
• Health Synergy Clinical Research — Boynton Beach
• … и ещё 5 центров

Идентификаторы

NCT: NCT07363577 · LB-102-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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