52-week Open Label Safety-Tolerability Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LB-102.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia
Overview
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia
Detailed description
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies
Interventions
- Drug LB-102
LB-102 flexible dosing 50 mg - 100 mg
Primary outcome measures
- Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. [Time frame: 52 weeks]
Secondary outcome measures (4)
- Evaluate long term safety and tolerability [Time frame: 52 weeks]
- Evaluate long term safety and tolerability [Time frame: 52 weeks]
- Evaluate long term safety and tolerability [Time frame: 52 weeks]
- Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS) [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- Provide ICF
- Patients clinically stable PANSS </= 70 at screening
- CGI-S </+ 3 at screening
- Medically stable
- BMI 18 -40
- Taking oral antipsychotic treatment for at least 30 days
- Have stable living environment
Exclusion criteria
- Sexually active M/F patients not willing to use highly effective contraception
- Breast feeding
- History of treatment resistance to schizophrenia medications
- DSM-5 current diagnosis other than schizophrenia
- Risk of suicidal behavior
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Chandler Clinical Trials — Chandler
- Pillar Clinical Research — Bentonville
- Pillar Clinical Research — Little Rock
- Woodland International Research Group — Little Rock
- Advanced Research Center — Anaheim
- Synapse Clinical Trials — Cerritos
- ProScience Research Group — Culver City
- CenExel — Culver City
- … and 15 more centers
Identifiers
NCT: NCT07369154 · LB-102-010