A Phase 3 interventional study of asenapine in Schizophrenia, Paranoid, Schizophrenia, Disorganized and Schizophrenia, Undifferentiated, sponsored by Organon and Co. Completed. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 204 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Also known as: Saphris®, SCH 900274, Org 5222
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.
Time frame: 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.
Time frame: Up to 26 weeks
| Milestone | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old |
|---|---|---|
| Started | 196 | 8 |
| Completed | 155 | 4 |
| Not completed | 41 | 4 |
| Withdrew: Adverse event | 10 | 0 |
| Withdrew: Treatment failure | 8 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 13 | 1 |
| Withdrew: Protocol violation | 8 | 1 |
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.
| participants | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old |
|---|---|---|
| Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study | 114 | 3 |
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.
| participants | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old |
|---|---|---|
| Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE | 10 | 0 |
Collected over Up to 30 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asenapine - Participants Who Were ≤17 Years Old | — | 7/196 (3.6%) | 59/196 (30.1%) |
| Asenapine - Participants Who Were 18 Years Old | — | 1/8 (12.5%) | 3/8 (37.5%) |
| Event | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old |
|---|---|---|
| ANXIETYPsychiatric disorders | 1/196 | 1/8 |
| SCHIZOPHRENIAPsychiatric disorders | 3/196 | 0/8 |
| AGGRESSIONPsychiatric disorders | 2/196 | 0/8 |
| MULTI-ORGAN FAILUREGeneral disorders | 1/196 | 0/8 |
| AGITATIONPsychiatric disorders | 1/196 | 0/8 |
| Event | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old |
|---|---|---|
| SOMNOLENCENervous system disorders | 29/196 | 0/8 |
| VISION BLURREDEye disorders | 1/196 | 1/8 |
| FATIGUEGeneral disorders | 5/196 | 1/8 |
| FEELING COLDGeneral disorders | 0/196 | 1/8 |
| PAINGeneral disorders | 1/196 | 1/8 |
| ACCIDENTAL OVERDOSEInjury, poisoning and procedural complications | 3/196 | 1/8 |
| INJURYInjury, poisoning and procedural complications | 0/196 | 1/8 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/196 | 1/8 |
| AKATHISIANervous system disorders | 4/196 | 1/8 |
| BRADYKINESIANervous system disorders | 0/196 | 1/8 |
All participants who received at least one dose of extension study medication
| Age, Continuous(years) | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old | Total |
|---|---|---|---|
| Mean | 15.3 ± 1.5 | 18 ± 0 | 15.4 ± 1.6 |
| Sex: Female, Male(Participants) | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old | Total |
|---|---|---|---|
| Female | 74 | 4 | 78 |
| Male | 122 | 4 | 126 |
No study locations are listed for this record.
Plan to share: No
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