Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
LB Pharmaceuticals Inc.
Study ID
NCT07363577
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LB-102 (50 mg tablet) — DRUG
    LB-102 oral tablet given for six weeks
  • LB-102 (100 mg tablet) — DRUG
    LB-102 oral tablet given for six weeks
  • Placebo — OTHER
    Placebo tablet given orally for six weeks

Study Details

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Key Dates

Start date
Mar 25, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LB-102 (50 mg tablet)
    • LB-102 50 mg given orally for 6 weeks
  • Experimental: LB-102 (100 mg tablet)
    LB-102 100 mg given orally for 6 weeks
  • Placebo Comparator: Placebo
    Placebo given orally for 6 weeks

Primary Outcome Measure

Change from baseline to Week 6 on the Positive and Negative Syndrome Scale [ Time Frame: 6 weeks ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Pillar Clinical ResearchBentonvilleArkansas72712
Fayz Hudefi, MD
[email protected]
479-367-2688
Pillar Clinical ResearchLittle RockArkansas72204
Leslie Smith, MD
[email protected]
501-307-1919
Nichole Gutierrez
[email protected]
501-307-1919
Woodland International Research GroupLittle RockArkansas72211
Ashley Poole
[email protected]
501-221-8681
ProScience Research GroupCulver CityCalifornia90230
Paola Aguirre
[email protected]
424-227-8127
CenExelGarden GroveCalifornia92845
Dakota Gainers
[email protected]
714-943-5874
Synergy San DiegoLemon GroveCalifornia92064
Corey Weise
[email protected]
619-303-6130
Clinical Innovations, Inc.RiversideCalifornia92506
Evagelos Coskinas, MD, PhD
[email protected]
866-236-3935
Health Synergy Clinical ResearchBoynton BeachFlorida33426
Katherine Grigelis
[email protected]
561-473-3472
Innovative Clinical ResearchMiami LakesFlorida33016
Melissa Rodco
[email protected]
305-722-8444
Luis Sotolongo
[email protected]
305-722-8444
Accelerated Clinical TrialSnellvilleGeorgia30078
Alexis Melson
[email protected]
978-255-1041
Pillar Clinical ResearchChicagoIllinois60641
Roueen Rafeyan, MD
[email protected]
224-534-7332
Nicole Gutierrez
[email protected]
479-367-2688
Arch Clinical TrialsSt LouisMissouri63141
Israa Diab
[email protected]
314-266-1243
Neuro-Behavioral Clinical ResearchNorth CantonOhio44720
Crystal Blackford
[email protected]
330-493-1118

Find similar trials in Bentonville, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research· Bentonville, ARPillar Clinical Research· Little Rock, ARWoodland International Research Group· Little Rock, ARProScience Research Group· Culver City, CACenExel· Garden Grove, CASynergy San Diego· Lemon Grove, CA

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