Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06690398
Phase
PHASE3
Status
Recruiting
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Conditions

  • Irritability Associated With Autism Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone high dose — DRUG
    Lumateperone administered orally once daily
  • Lumateperone low dose — DRUG
    Lumateperone administered orally once daily
  • Placebo — DRUG
    Matching Placebo administered orally once daily

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Key Dates

Start date
Nov 22, 2024
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Lumateperone high dose
    Lumateperone 42 mg for patients ages 13-17 years old
  • Experimental: Lumateperone low dose
    Lumateperone 21 mg for patients ages 13-17 years old
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Aberrant Behavior Checklist - Irritability (ABC-I) [ Time Frame: Week 6 ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
Clinical SiteDothanAlabama36303-
Clinical SitePeoriaArizona85382-
Clinical SitePhoenixArizona85006-
Clinical SiteAnaheimCalifornia92805-
Clinical SiteBuena ParkCalifornia90621-
Clinical SiteCoronaCalifornia92879-
Clinical SiteOceansideCalifornia92056-
Clinical SiteRedlandsCalifornia92373-
Clinical SiteUplandCalifornia91786-
Clinical SiteWest CovinaCalifornia91790-
Clinical SiteColorado SpringsColorado80910-
Clinical SiteGainesvilleFlorida32607-
Clinical SiteJacksonvilleFlorida32258-
Clinical SiteMiamiFlorida33125-
Clinical SiteMiamiFlorida33175-
Clinical SiteMiamiFlorida33176-
Clinical SiteMiamiFlorida33186-
Clinical SiteMiami LakesFlorida33016-
Clinical SiteMiami SpringsFlorida33166-
Clinical SiteWest Palm BeachFlorida33407-
Clinical SiteSavannahGeorgia31405-
Clinical SiteArlington HeightsIllinois60005-
Clinical SiteSpringfieldIllinois62701-
Clinical SiteBostonMassachusetts02114-
Clinical SiteSaint CharlesMissouri63304-
Clinical SiteLas VegasNevada89128-
Clinical SiteCincinnatiOhio45229-
Clinical SiteGarfieldOhio44125-
Clinical SiteWestlakeOhio44145-
Clinical SiteNashvilleTennessee37203-
Clinical SiteDallasTexas75251-
Clinical SiteFriscoTexas75034-
Clinical SiteHoustonTexas77089-
Clinical SitePlanoTexas75093-
Clinical SiteRichmondTexas77407-
Clinical SitePetersburgVirginia23805-
Clinical SiteBellevueWashington98007-

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