Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

October 22, 2021

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Bipolar I DisorderSchizophrenia
Interventions
DRUG

OLZ/SAM

Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Trial Locations (40)

1900

Alkermes Investigational Site, La Plata

5500

Alkermes Investigational Site, Mendoza

20010

Alkermes Investigational Site, Washington D.C.

23220

Alkermes Investigational Site, Richmond

30030

Alkermes Investigational Site, Decatur

33016

Alkermes Investigational Site, Miami Lakes

33155

Alkermes Investigational Site, Miami

36303

Alkermes Investigational Site, Dothan

37000

Alkermes Investigational Site, León

45069

Alkermes Investigational Site, West Chester

45229

Alkermes Investigational Site, Cincinnati

46202

Alkermes Investigational Site, Indianapolis

51053

Alkermes Investigational Site, Bello

60611

Alkermes Investigational Site, Chicago

63304

Alkermes Investigational Site, Saint Charles

64620

Alkermes Investigational Site, Monterrey

64710

Alkermes Investigational Site, Monterrey

68131

Alkermes Investigational Site, Omaha

68526

Alkermes Investigational Site, Lincoln

72204

Alkermes Investigational Site, Little Rock

75115

Alkermes Investigational Site, DeSoto

76104

Alkermes Investigational Site, Fort Worth

80020

Alkermes Investigational Site, Bogotá

80202

Alkermes Investigator Site, Denver

80230

Alkermes Investigational Site, Culiacán

94305

Alkermes Investigational Site, Stanford

98201

Alkermes Investigational Site, Everett

110121

Alkermes Investigational Site, Barranquilla

111166

Alkermes Investigational Site, Bogotá

660003

Alkermes Investigational Site, Pereira

C1181ACH

Alkermes Investigational Site, Ciudad Autonoma de Buenos Aire

C1133AAH

Alkermes Investigational Site, Buenos Aires

X5003DCE

Alkermes Investigational Site, Córdoba

60430-140

Alkermes Investigational Site, Fortaleza

80240-280

Alkermes Investigational Site, Curitiba

22270-060

Alkermes Investigational Site, Rio de Janeiro

05403-010

Alkermes Investigational Site, São Paulo

74093-040

Alkermes Investigational Site, Goiânia

01228-000

Alkermes Investigational Site, São Paulo

C.P. 07000

Alkermes Investigational Site, Gustavo A. Madero

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY