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52-week Open Label Safety-Tolerability Study
52-week Open Label Safety-Tolerability Study

NCT07369154

RecruitingPhase 3

Sponsor: LB Pharmaceuticals Inc.

Conditions: Schizophrenia

Interventions: LB-102

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (23)
  • Chandler, Arizona, United States
  • Bentonville, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Anaheim, California, United States
  • Cerritos, California, United States
  • Culver City, California, United States
  • Culver City, California, United States
  • San Diego, California, United States
  • Hollywood, Florida, United States
  • Miami Lakes, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Snellville, Georgia, United States
  • Chicago, Illinois, United States
  • Gaithersburg, Maryland, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Canton, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • DeSoto, Texas, United States
  • Richardson, Texas, United States