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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04987229




Registration number
NCT04987229
Ethics application status
Date submitted
26/07/2021
Date registered
3/08/2021
Date last updated
30/10/2024

Titles & IDs
Public title
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Scientific title
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects with Schizophrenia or Bipolar I Disorder
Secondary ID [1] 0 0
ALKS 3831-A313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OLZ/SAM

Experimental: All subjects - 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: Drugs: OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
Up to 52 weeks

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
236
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Cordoba
Country [13] 0 0
Argentina
State/province [13] 0 0
Mendoza
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autonoma Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma de Buenos Aires
Country [16] 0 0
Brazil
State/province [16] 0 0
Ceará
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio de Janeiro
Country [18] 0 0
Brazil
State/province [18] 0 0
São Paulo
Country [19] 0 0
Colombia
State/province [19] 0 0
Barranquilla
Country [20] 0 0
Colombia
State/province [20] 0 0
Bello
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogotá
Country [22] 0 0
Colombia
State/province [22] 0 0
Pereira
Country [23] 0 0
Malaysia
State/province [23] 0 0
Johor
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kedah
Country [25] 0 0
Malaysia
State/province [25] 0 0
Negeri Sembilan
Country [26] 0 0
Malaysia
State/province [26] 0 0
Putrajaya
Country [27] 0 0
Mexico
State/province [27] 0 0
Estado De Mexico
Country [28] 0 0
Mexico
State/province [28] 0 0
Guanajuato
Country [29] 0 0
Mexico
State/province [29] 0 0
Jalisco
Country [30] 0 0
Mexico
State/province [30] 0 0
Nuevo León
Country [31] 0 0
Mexico
State/province [31] 0 0
San Luis Potos
Country [32] 0 0
Mexico
State/province [32] 0 0
Sinaloa
Country [33] 0 0
Mexico
State/province [33] 0 0
Durango

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Trial website
https://clinicaltrials.gov/study/NCT04987229
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
David McDonnell, MD
Address 0 0
Alkermes, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04987229