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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06706674
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
Dec 6, 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 (39)

FacilityCityStateZIPSite coordinators
Clinical SiteLittle RockArkansas72204-
Clinical SiteImperialCalifornia92251-
Clinical SiteSacramentoCalifornia95817-
Clinical SiteSherman OaksCalifornia91403-
Clinical SiteNew HavenConnecticut06511-
Clinical SiteHialeahFlorida33012-
Clinical SiteMiamiFlorida33122-
Clinical SiteMiamiFlorida33130-
Clinical SiteMiamiFlorida33144-
Clinical SiteMiamiFlorida33165-
Clinical SiteMiamiFlorida33173-
Clinical SiteMiami GardensFlorida33056-
Clinical SiteMiami LakesFlorida33014-
Clinical SiteOrlandoFlorida32803-
Clinical SiteOrlandoFlorida32809-
Clinical SitePompano BeachFlorida33060-
Clinical SiteAtlantaGeorgia30318-
Clinical SiteLawrencevilleGeorgia30046-
Clinical SiteNapervilleIllinois60563-
Clinical SiteEvansvilleIndiana47713-
Clinical SiteIndianapolisIndiana46202-
Clinical SiteBostonMassachusetts02115-
Clinical SiteBloomfield HillsMichigan48302-
Clinical SiteSt LouisMissouri63108-
Clinical SiteLincolnNebraska68526-
Clinical SiteOrangeburgNew York10962-
Clinical SiteStaten IslandNew York10314-
Clinical SiteThe BronxNew York10467-
Clinical SiteKinstonNorth Carolina28504-
Clinical SiteAvon LakeOhio44012-
Clinical SiteOklahoma CityOklahoma73116-
Clinical SiteCharlestonSouth Carolina29425-
Clinical SiteAustinTexas78759-
Clinical SiteCoppellTexas75019-
Clinical SiteDallasTexas75251-
Clinical SiteFort WorthTexas76104-
Clinical SiteHoustonTexas77090-
Clinical SiteRichmondVirginia23220-
Clinical SiteEverettWashington98201-

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