Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT06572449
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • KarXT — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

Key Dates

Start date
Oct 28, 2024
Status verified
Mar 2025
Primary completion
Mar 13, 2025
Completion
Mar 13, 2025

Study Design

Enrollment
173 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT on empty stomach and with food

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 11 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Local Institution - 0002Los AlamitosCalifornia90720-3118-
Local Institution - 0004RiversideCalifornia92506-3257-
Local Institution - 0006HollywoodFlorida33024-
Local Institution - 0005AtlantaGeorgia30331-
Local Institution - 0003DecaturGeorgia30030-
Local Institution - 0001MarltonNew Jersey08053-3449-

Find similar trials in Los Alamitos, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Local Institution - 0002· Los Alamitos, CALocal Institution - 0004· Riverside, CALocal Institution - 0006· Hollywood, FLLocal Institution - 0005· Atlanta, GALocal Institution - 0003· Decatur, GALocal Institution - 0001· Marlton, NJ

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