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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018038-12 | EudraCT Number | ||
| MK-8274-021 | Other Identifier | Merck Research Laboratories |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26091193 | Result | Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine - Participants Who Were ≤17 Years Old | In this extension study all participants received open-label asenapine 2.5 mg twice daily (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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of extension study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of extension study medication | Posted | Number | participants | Up to 30 weeks |
|
Up to 30 weeks
The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VISION BLURRED | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012563 | Schizophrenia, Paranoid |
| D012562 | Schizophrenia, Disorganized |
| D012559 | Schizophrenia |
| D012734 | Disorders of Sex Development |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Protocol Violation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
|
|
| 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. | All participants who received at least one dose of extension study medication | Posted | Number | participants | Up to 26 weeks |
|
|
|
| 7 |
| 196 |
| 59 |
| 196 |
| EG001 | 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. | 1 | 8 | 3 | 8 |
| AGGRESSION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 16.0 | Systematic Assessment |
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| FEELING COLD | General disorders | MedDRA 16.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 16.0 | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| INJURY | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| AKATHISIA | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| BRADYKINESIA | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| COGWHEEL RIGIDITY | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| RESTING TREMOR | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
It is planned to first publish/present trial results together with the other sites, unless permission is obtained from Sponsor to publish separate results. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. If there is disagreement concerning appropriateness of the materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve disagreement prior to submission for publication.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |