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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04987229
Other study ID # ALKS 3831-A313
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date October 22, 2021
Est. completion date September 2027

Study information

Verified date November 2023
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 236
Est. completion date September 2027
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion. - Subject will benefit from continued therapy with OLZ/SAM per clinical judgment. - Subject is able to be treated on an outpatient basis. - Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. - Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. - Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study. Exclusion Criteria: - Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit. - Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement. - Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine - Subject has a positive test for opioids. - Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Locations

Country Name City State
Argentina Alkermes Investigational Site Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Alkermes Investigational Site Ciudad Autonoma de Buenos Aires
Argentina Alkermes Investigational Site Ciudad de Cordoba Cordoba
Argentina Alkermes Investigational Site Ciudad de Mendoza Mendoza
Argentina Alkermes Investigational Site Cordoba
Brazil Alkermes Investigational Site Curitiba Parana
Brazil Alkermes Investigational Site Fortaleza Ceará
Brazil Alkermes Investigational Site Goiania
Brazil Alkermes Investigational Site Rio de Janeiro
Brazil Alkermes Investigational Site Sao Paulo
Brazil Alkermes Investigational Site São Paulo
Colombia Alkermes Investigational Site Barranquilla
Colombia Alkermes Investigational Site Bello
Colombia Alkermes Investigational Site Bogotá
Colombia Alkermes Investigational Site Bogotá
Colombia Alkermes Investigational Site Pereira
Mexico Alkermes Investigational Site Culiacán Sinaloa
Mexico Alkermes Investigational Site Gustavo A. Madero Estado De Mexico
Mexico Alkermes Investigational Site León Guanajuato
Mexico Alkermes Investigational Site Monterrey Nuevo León
Mexico Alkermes Investigational Site Monterrey Nuevo León
Mexico Alkermes Investigational Site San Luis Potosí San Luis Potos
United States Alkermes Investigational Site Chicago Illinois
United States Alkermes Investigational Site Cincinnati Ohio
United States Alkermes Investigational Site Colorado Springs Colorado
United States Alkermes Investigational Site Decatur Georgia
United States Alkermes Investigational Site DeSoto Texas
United States Alkermes Investigational Site Dothan Alabama
United States Alkermes Investigational Site Encino California
United States Alkermes Investigational Site Everett Washington
United States Alkermes Investigational Site Fort Worth Texas
United States Alkermes Investigational Site Hartford Connecticut
United States Alkermes Investigational Site Indianapolis Indiana
United States Alkermes Investigational Site Kansas City Kansas
United States Alkermes Investigational Site Kinston North Carolina
United States Alkermes Investigational Site Lincoln Nebraska
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Miami Lakes Florida
United States Alkermes Investigational Site Saint Charles Missouri
United States Alkermes Investigational Site Stanford California
United States Alkermes Investigational Site Upland California
United States Alkermes Investigational Site Washington District of Columbia
United States Alkermes Investigational Site West Chester Ohio

Sponsors (1)

Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Up to 52 weeks
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