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

Alkermes

Status and phase: Invitation-only; Phase 3

Conditions: Schizophrenia; Bipolar I Disorder

Treatments: Drug: OLZ/SAM

Study type: Interventional

Funder types: Industry

Identifiers

NCT04987229

ALKS 3831-A313

Details and patient eligibility

About

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

Enrollment: 236 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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236 participants in 1 patient group

All subjects

Experimental group

Description:

All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)

Treatment:

Drug: OLZ/SAM