52-week Open Label Safety-Tolerability Study
Recruiting · NCT07369154 · Interventional (participants receive a specific treatment) · Lead sponsor: LB Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
LB-102
What this trial is about
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 can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
23 locations listed across 13 US states.
- Chandler Clinical Trials - Chandler, Arizona, United States
- Pillar Clinical Research - Bentonville, Arkansas, United States
- Pillar Clinical Research - Little Rock, Arkansas, United States
- Woodland International Research Group - Little Rock, Arkansas, United States
- Advanced Research Center - Anaheim, California, United States
- Synapse Clinical Trials - Cerritos, California, United States
- ProScience Research Group - Culver City, California, United States
- CenExel - Culver City, California, United States
- Synergy San Diego - San Diego, California, United States
- CenExel - Hollywood, Florida, United States
- Segal Trials - Miami Lakes, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- CenExel - Atlanta, Georgia, United States
- Accelerated Clinical Trial - Snellville, Georgia, United States
- Pillar Clinical Research - Chicago, Illinois, United States
- CenExel Gaithersburg - Gaithersburg, Maryland, United States
- Arch Clinical Trials - St Louis, Missouri, United States
- Redbird Research - Las Vegas, Nevada, United States
- Neuro-Behavioral Clinical Research - New York, New York, United States
- Neuro-Behavioral Clinical Research - Canton, Ohio, United States
- Adams Clinical - Philadelphia, Pennsylvania, United States
- Adams Clinical - DeSoto, Texas, United States
- Pillar Clinical Research - Richardson, Texas, United States