This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to examine the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. The primary objective of the study is to assess the efficacy of LB-102 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores at day 28 in approximately 350 adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in CGI-S, PANSS subscale and Marder Factor scores, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia. The duration of treatment of the study is 28 days (4 weeks). Patients in this study will be randomized 3:3:3:1 to receive either: placebo, 50 mg QD LB-102, 75 mg QD LB-102, or 100 mg QD LB-102; that is, \~105 patients will get placebo, \~105 will get 50 mg LB-102 QD, \~105 will get 75 mg LB-102 QD, \~35 will get 100 mg LB-102 QD. LB-102 will be dosed orally once a day. Pharmacokinetic data will be measured for the first 60 patients in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
359
LB-102 is a dopamine D2/3 and 5HT7 antagonist.
Pillar Clinical Research
Bentonville, Arkansas, United States
Woodland Internation Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
CelExel Clinical Innovations
Bellflower, California, United States
Synexus
Cerritos, California, United States
ProScience Research Group
Culver City, California, United States
CelExel CNS
Garden Grove, California, United States
Synergy Research
Lemon Grove, California, United States
CenExel CIT Riverside
Riverside, California, United States
NRC Research Institute
Santa Ana, California, United States
...and 15 more locations
Change From Baseline to Week 4 in the PANSS Total Score
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
Time frame: Baseline to Day 28 (4 weeks)
Change From Baseline to Week 4 in the CGI-S Score
The Clinical Global Impressions-Severity (CGI-S) rates illness severity on a scale from 1 to 7 and has been shown to correlate with PANSS. The CGI-S is rated on a 7-point scale commonly used in clinical settings and research to evaluate the severity of symptoms and treatment responses in patients with mental disorders. The CGI-S specifically focuses on the severity of illness at the time of assessment, where clinicians assess the patient's current condition relative to their past. The scoring is for the CGI-S:1-normal, not at all ill, 2-Borderline mentally ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, and 7-Extremely ill. The higher the score the more ill the patient is.
Time frame: 28 days
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