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
Apply to this trial

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

First listed
Nov 26, 2024
Start date
Dec 6, 2024
Status verified
Jul 2026
Primary completion
Jun 21, 2027
Completion
Jun 21, 2027

Study Design

Enrollment
160 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 (38)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research, LLCLittle RockArkansas72204-
University Of California - DavisSacramentoCalifornia95817-
California Neuroscience ResearchSherman OaksCalifornia91403-
Yale University School Of MedicineNew HavenConnecticut06519-
United Research InstituteHialeahFlorida33012-
Advanced Research Institute of MiamiHomesteadFlorida33033-
AP Medical ResearchMiamiFlorida33165-
Blue Medical ResearchMiamiFlorida33144-
Care Research Center IncMiamiFlorida33130-
Vital Care ResearchMiamiFlorida33122-
New Med Research IncMiami GardensFlorida33056-
Riveldi Biomedical ResearchMiami LakesFlorida33014-
APG Research LLCOrlandoFlorida32803-
Orlando Psychiatric AssociatesOrlandoFlorida32809-
Clinical Research Center of FloridaPompano BeachFlorida33060-
University of South Florida Rothman Center of NeuropsychiatrySt. PetersburgFlorida33701-
Advanced Discovery ResearchAtlantaGeorgia30318-
Salveo Integrative Health IncLawrencevilleGeorgia30046-
EmVenio Research at ChicagoChicagoIllinois60622-
Baber Research GroupNapervilleIllinois60563-
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202-
Louisiana State University Health Sciences Center ShreveportShreveportLouisiana71101-
Neurobehavioral Medicine GroupBloomfield HillsMichigan48302-
Alivation Research LLCLincolnNebraska68526-
NYU Child Study CenterNew YorkNew York10016-
Nathan Kline InstituteOrangeburgNew York10962-
Richmond Behavioral AssociatesStaten IslandNew York10314-
Advantage Clinical TrialsThe BronxNew York10467-
Quest Therapeutics of Avon LakeAvon LakeOhio44012-
Sooner Clinical ResearchOklahoma CityOklahoma73116-
SP Research, PLLC (dba Rivus Wellness & Research Institute)Oklahoma CityOklahoma73112-
Medical University of South CarolinaCharlestonSouth Carolina29425-
BioBehavioral Research of Austin PCAustinTexas78759-
Future Search Trials of DallasDallasTexas75251-
North Texas Clinical TrialsFort WorthTexas76104-
Red Oak Psychiatry AssociatesHoustonTexas77090-
Virginia Commonwealth UniversityRichmondVirginia23220-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Little Rock, AR

By research site
Pillar Clinical Research, LLC· Little Rock, ARUniversity Of California - Davis· Sacramento, CACalifornia Neuroscience Research· Sherman Oaks, CAYale University School Of Medicine· New Haven, CTUnited Research Institute· Hialeah, FLAdvanced Research Institute of Miami· Homestead, FL

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