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
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 15, 2024
Start date
Nov 22, 2024
Status verified
Jul 2026
Primary completion
Jun 21, 2027
Completion
Jul 19, 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 (35)

FacilityCityStateZIPSite coordinators
Harmonex Neuroscience ResearchDothanAlabama36303-
Southwest Autism Research and Resource CenterPhoenixArizona85006-
Advanced Research Center IncAnaheimCalifornia92805-
Excell Research IncOceansideCalifornia92056-
Inland Psychiatric Medical Group IncRedlandsCalifornia92373-
Buena Park ResearchUplandCalifornia91786-
Next Level Clinical Trials, LLCWest CovinaCalifornia91790-
MCB Clinical Research Centers LLCColorado SpringsColorado80910-
Royal Palm Clinical ResearchFort MyersFlorida33901-
Sarkis Clinical TrialsGainesvilleFlorida32607-
Green Leaf Clinical TrialsJacksonvilleFlorida32258-
Anchor Medical Research LLCMiamiFlorida33176-
Columbus Clinical Services LLCMiamiFlorida33125-
Diverse Clinical Research LLCMiamiFlorida33175-
Links Clinical TrialsMiamiFlorida33176-
South Florida Research Phase I-IVMiamiFlorida33166-
The Angel Medical Research CorporationMiami GardensFlorida33169-
Health Synergy Clinical ResearchWest Palm BeachFlorida33407-
CenExeli Research LLCSavannahGeorgia31405-
Revive Research InstituteElginIllinois60123-
Southern Illinois University School of MedicineSpringfieldIllinois62701-
Massachusetts General HospitalBostonMassachusetts02114-
UMass Memorial HealthcareWorcesterMassachusetts01655-
Midwest Research GroupSaint CharlesMissouri63304-
Vector Clinical TrialsLas VegasNevada89128-
Charak Center for Health and WellnessGarfieldOhio44125-
Westlake Brain HealthWestlakeOhio44145-
Access Clinical TrialsNashvilleTennessee37203-
REX Clinical Trials LLCBeaumontTexas77701-
North Pointe PsychiatryFlower MoundTexas76028-
Kaleidoscope Clinical ResearchHoustonTexas77089-
AIM TrialsPlanoTexas75093-
Perceptive Pharma ResearchRichmondTexas77407-
Clinical Research Partners, LLCPetersburgVirginia23805-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Dothan, AL

By research site
Harmonex Neuroscience Research· Dothan, ALSouthwest Autism Research and Resource Center· Phoenix, AZAdvanced Research Center Inc· Anaheim, CAExcell Research Inc· Oceanside, CAInland Psychiatric Medical Group Inc· Redlands, CABuena Park Research· Upland, CA

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