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

PHASE3RecruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

November 22, 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 (37)

23805

RECRUITING

Clinical Site, Petersburg

31405

RECRUITING

Clinical Site, Savannah

32258

RECRUITING

Clinical Site, Jacksonville

32607

RECRUITING

Clinical Site, Gainesville

33016

RECRUITING

Clinical Site, Miami Lakes

33125

RECRUITING

Clinical Site, Miami

33166

RECRUITING

Clinical Site, Miami Springs

33175

RECRUITING

Clinical Site, Miami

33176

RECRUITING

Clinical Site, Miami

33186

RECRUITING

Clinical Site, Miami

33407

RECRUITING

Clinical Site, West Palm Beach

36303

RECRUITING

Clinical Site, Dothan

37203

RECRUITING

Clinical Site, Nashville

44125

RECRUITING

Clinical Site, Garfield

44145

RECRUITING

Clinical Site, Westlake

45229

NOT_YET_RECRUITING

Clinical Site, Cincinnati

60005

NOT_YET_RECRUITING

Clinical Site, Arlington Heights

62701

RECRUITING

Clinical Site, Springfield

63304

RECRUITING

Clinical Site, Saint Charles

75034

NOT_YET_RECRUITING

Clinical Site, Frisco

75093

RECRUITING

Clinical Site, Plano

75251

NOT_YET_RECRUITING

Clinical Site, Dallas

77089

RECRUITING

Clinical Site, Houston

77407

RECRUITING

Clinical Site, Richmond

80910

RECRUITING

Clinical Site, Colorado Springs

85006

RECRUITING

Clinical Site, Phoenix

85382

NOT_YET_RECRUITING

Clinical Site, Peoria

89128

RECRUITING

Clinical Site, Las Vegas

90621

NOT_YET_RECRUITING

Clinical Site, Buena Park

91786

RECRUITING

Clinical Site, Upland

91790

RECRUITING

Clinical Site, West Covina

92056

RECRUITING

Clinical Site, Oceanside

92373

RECRUITING

Clinical Site, Redlands

92805

RECRUITING

Clinical Site, Anaheim

92879

NOT_YET_RECRUITING

Clinical Site, Corona

98007

RECRUITING

Clinical Site, Bellevue

02114

NOT_YET_RECRUITING

Clinical Site, Boston

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY