Schizophrenia
Conditions
Brief summary
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
DRUGLB-102
LB-102 flexible dosing 50 mg - 100 mg
Sponsors
LB Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provide ICF * Patients clinically stable PANSS \</= 80 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. | 52 weeks | Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate long term safety and tolerability | 52 weeks | Evaluating the safety of treatment by number of adverse events |
| Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS) | 52 weeks | Change in Positive and Negative Syndrome Scale (PANSS) from Baseline to end of treatment where a decrease in score likely indicate response to treatment whereas an increase in score may indicate a worsening of disease where an increase in the scale score may indicate a worsening of disease and decrease in score likely indicates response to treatment. |
Countries
United States
Contacts
CONTACTBranislav Mancevski, MD
Outcome results
None listed