Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07467993
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • GXV813 — DRUG
    GXV813 administered orally.
  • Placebo — DRUG
    Placebo administered orally.

Study Details

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Key Dates

Start date
Mar 16, 2026
Status verified
May 2026
Primary completion
Apr 22, 2027
Completion
Apr 22, 2027

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GXV813
    GXV813 administered orally.
  • Placebo Comparator: Placebo
    Placebo administered orally.

Primary Outcome Measure

Change from baseline in Positive and Negative Symptom Scale (PANSS) total score [ Time Frame: Baseline, Week 6 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (7)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research LLCBentonvilleArkansas72712
Leslie Smith (PRINCIPAL_INVESTIGATOR)
CNRI Los Angeles LLCPico RiveraCalifornia90660
Mohamed El-Gabalawy (PRINCIPAL_INVESTIGATOR)
Segal Institute for Clinical ResearchMiamiFlorida33016
Rishi Kakar (PRINCIPAL_INVESTIGATOR)
CenExel iResearchDecaturGeorgia30030
Kimball Johnson (PRINCIPAL_INVESTIGATOR)
Pillar Clinical Research LLCChicagoIllinois60641
Scott Bartley (PRINCIPAL_INVESTIGATOR)
Uptown Research Institute LLCChicagoIllinois60640
John Sonnenberg (PRINCIPAL_INVESTIGATOR)
Arch Clinical Trials LLCSt LouisMissouri63141
Syed Junaid (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bentonville, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research LLC· Bentonville, ARCNRI Los Angeles LLC· Pico Rivera, CASegal Institute for Clinical Research· Miami, FLCenExel iResearch· Decatur, GAPillar Clinical Research LLC· Chicago, ILUptown Research Institute LLC· Chicago, IL

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