Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Undifferentiated
Conditions
Brief summary
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.
Interventions
DRUGasenapine
asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study | Up to 30 weeks | 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. |
| Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE | Up to 26 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asenapine - Participants Who Were ≤17 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study. | 196 |
| Asenapine - Participants Who Were 18 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study. | 8 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Protocol Violation | 8 | 1 |
| Overall Study | Treatment Failure | 8 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 1 |
Baseline characteristics
| Characteristic | Asenapine - Participants Who Were ≤17 Years Old | Asenapine - Participants Who Were 18 Years Old | Total |
|---|---|---|---|
| Age, Continuous | 15.3 years STANDARD_DEVIATION 1.5 | 18 years STANDARD_DEVIATION 0 | 15.4 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 74 Participants | 4 Participants | 78 Participants |
| Sex: Female, Male Male | 122 Participants | 4 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 196 | 3 / 8 |
| serious Total, serious adverse events | 7 / 196 | 1 / 8 |
Outcome results
Primary
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
Population: All participants who received at least one dose of extension study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Asenapine - Participants Who Were ≤17 Years Old | Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE | 10 participants |
| Asenapine - Participants Who Were 18 Years Old | Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE | 0 participants |
Primary
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
Population: All participants who received at least one dose of extension study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Asenapine - Participants Who Were ≤17 Years Old | Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study | 114 participants |
| Asenapine - Participants Who Were 18 Years Old | Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study | 3 participants |