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

PHASE3RecruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

December 6, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

April 30, 2027

Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
DRUG

Lumateperone high dose

Lumateperone administered orally once daily

DRUG

Lumateperone low dose

Lumateperone administered orally once daily

DRUG

Placebo

Matching Placebo administered orally once daily

Trial Locations (39)

10314

RECRUITING

Clinical Site, Staten Island

10467

RECRUITING

Clinical Site, The Bronx

10962

RECRUITING

Clinical Site, Orangeburg

23220

RECRUITING

Clinical Site, Richmond

28504

NOT_YET_RECRUITING

Clinical Site, Kinston

29425

NOT_YET_RECRUITING

Clinical Site, Charleston

30046

RECRUITING

Clinical Site, Lawrenceville

30318

RECRUITING

Clinical Site, Atlanta

32803

RECRUITING

Clinical Site, Orlando

32809

RECRUITING

Clinical Site, Orlando

33012

RECRUITING

Clinical Site, Hialeah

33014

RECRUITING

Clinical Site, Miami Lakes

33056

RECRUITING

Clinical Site, Miami Gardens

33060

RECRUITING

Clinical Site, Pompano Beach

33122

RECRUITING

Clinical Site, Miami

33130

RECRUITING

Clinical Site, Miami

33144

RECRUITING

Clinical Site, Miami

33165

RECRUITING

Clinical Site, Miami

33173

RECRUITING

Clinical Site, Miami

44012

RECRUITING

Clinical Site, Avon Lake

46202

RECRUITING

Clinical Site, Indianapolis

47713

NOT_YET_RECRUITING

Clinical Site, Evansville

48302

RECRUITING

Clinical Site, Bloomfield Hills

60563

RECRUITING

Clinical Site, Naperville

63108

NOT_YET_RECRUITING

Clinical Site, St Louis

68526

RECRUITING

Clinical Site, Lincoln

72204

RECRUITING

Clinical Site, Little Rock

73116

RECRUITING

Clinical Site, Oklahoma City

75019

NOT_YET_RECRUITING

Clinical Site, Coppell

75251

RECRUITING

Clinical Site, Dallas

76104

RECRUITING

Clinical Site, Fort Worth

77090

RECRUITING

Clinical Site, Houston

78759

RECRUITING

Clinical Site, Austin

91403

RECRUITING

Clinical Site, Sherman Oaks

92251

NOT_YET_RECRUITING

Clinical Site, Imperial

95817

NOT_YET_RECRUITING

Clinical Site, Sacramento

98201

RECRUITING

Clinical Site, Everett

06511

NOT_YET_RECRUITING

Clinical Site, New Haven

02115

NOT_YET_RECRUITING

Clinical Site, Boston

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY