NCT06557902 - Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 10, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions

Autism Spectrum Disorder

Interventions

DRUG

Lumateperone 10.5 mg capsule

Lumateperone 10.5 mg capsule, oral administration

DRUG

Lumateperone 21 mg capsule

Lumateperone 21 mg capsule, oral administration

DRUG

Lumateperone 5 mg ODT

Lumateperone 5 mg ODT, oral administration

DRUG

Lumateperone 10.5 mg ODT

Lumateperone 10.5 mg ODT, oral administration

DRUG

Lumateperone 15.5 mg ODT

Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration

DRUG

Lumateperone 21 mg ODT

Lumateperone 21 mg ODT, oral administration

Trial Locations (8)

30030

RECRUITING

Clinical Site 2, Decatur

30331

RECRUITING

Clinical Site 1, Atlanta

31405

RECRUITING

Clinical Site 3, Savannah

32803

NOT_YET_RECRUITING

Clinical Site 7, Orlando

33133

NOT_YET_RECRUITING

Clinical Site 6, Miami

63304

RECRUITING

Clinical Site 4, Saint Charles

68526

RECRUITING

Clinical Site 5, Lincoln

98201

RECRUITING

Clinical Site 8, Everett