Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

Study Overview
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Brief Summary
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This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.

Official Title
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A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

Conditions
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Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Undifferentiated

Intervention / Treatment
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* Drug: asenapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met. Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator's judgment, would benefit from long-term treatment. Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator. Exclusion Criteria: A female participant must not be pregnant and must not have the intention to become pregnant during the trial. A participant must not be at imminent risk of self-harm or harm to others. A participant must not currently be under involuntary inpatient commitment.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asenapine<br>All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigator's discretion). Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigator's discretion, based on tolerability and/or symptomatology. | Drug: asenapine<br>* asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID<br>* Other names: Saphris®, SCH 900274, Org 5222;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a treatment-emergent AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period. | Up to 30 weeks | 
| Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 26 weeks |