52-week Open Label Safety-Tolerability Study
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- LB Pharmaceuticals Inc.
- Study ID
- NCT07369154
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- LB-102 — DRUGLB-102 flexible dosing 50 mg - 100 mg
Study Details
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
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 900 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: LB-102An open label study
Primary Outcome Measure
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 ]
Central Contacts
- Anna Eramo, MD212-605-0300
- Branislav Mancevski, MD212-605-0300
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Chandler Clinical Trials | Chandler | Arizona | 85224 | |
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | Fayz Hudefi, MD (PRINCIPAL_INVESTIGATOR) |
| Pillar Clinical Research | Little Rock | Arkansas | 72204 | Leslie Smith, MD (PRINCIPAL_INVESTIGATOR) |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | |
| Advanced Research Center | Anaheim | California | 92805 | |
| Synapse Clinical Trials | Cerritos | California | 90703 | |
| CenExel | Culver City | California | 92845 | |
| ProScience Research Group | Culver City | California | 90230 | |
| Synergy San Diego | San Diego | California | 92064 | |
| CenExel | Hollywood | Florida | 33024 | Edwin Gomez, MD (PRINCIPAL_INVESTIGATOR) |
| Segal Trials | Miami Lakes | Florida | 33063 | |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | |
| CenExel | Atlanta | Georgia | 30331 | |
| Accelerated Clinical Trial | Snellville | Georgia | 30078 | |
| Pillar Clinical Research | Chicago | Illinois | 60641 | Betty Davis Roueen Rafeyan, MD (PRINCIPAL_INVESTIGATOR) |
| CenExel Gaithersburg | Gaithersburg | Maryland | 20877 | |
| Arch Clinical Trials | St Louis | Missouri | 63141 | |
| Redbird Research | Las Vegas | Nevada | 89119 | |
| Neuro-Behavioral Clinical Research | New York | New York | 11516 | |
| Neuro-Behavioral Clinical Research | Canton | Ohio | 44720 | Nate Fontes 330-493-1118 |
| Adams Clinical | Philadelphia | Pennsylvania | 19104 | Isabel Bear |
| Adams Clinical | DeSoto | Texas | 75115 | |
| Pillar Clinical Research | Richardson | Texas | 75080 |
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