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| ID | Type | Description | Link |
|---|---|---|---|
| Hera; | |||
| 41513 |
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Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.
The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol/Haloperidol | Active Comparator | Haloperidol in original study (NCT00156104) and in current long-term extension. |
|
| Asenapine/Asenapine | Experimental | Asenapine in original study and asenapine in current long-term extension. |
|
| Placebo/Asenapine | Experimental | Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52-week trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol | Drug | 2-8 mg BID |
| |
| Asenapine |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of Effect Over Time | Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy. | Throughout the 52 weeks of the trial. |
| Median Survival Time of Effect | Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy. | 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Note that one participant in each of the Placebo/Asenapine and Asenapine/Asenapine groups was enrolled but did not receive treatment. Thus, the numbers who started the period will be greater than the numbers presented at baseline and for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Asenapine | Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension |
| FG001 | Asenapine/Asenapine | Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension |
| FG002 | Haloperidol/Haloperidol | Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Asenapine | Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension |
| BG001 | Asenapine/Asenapine | Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension |
| 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 | Loss of Effect Over Time | Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy. | These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension. | Posted | Number | Participants | Throughout the 52 weeks of the trial. |
|
Adverse events (AEs) were monitored continually through 52 weeks of treatment and 1 month of posttreatment follow-up.
Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all serious AEs and treatment-emergent nonserious AEs.
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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 | Placebo/Asenapine | Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRUG EXPOSURE DURING PREGNANCY | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| C522667 | asenapine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Drug |
5 or 10 mg BID |
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| Asenapine | Drug | 5 or 10 mg BID |
|
| Lack of Efficacy |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Other |
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| BG002 | Haloperidol/Haloperidol | Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo/Asenapine |
Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension |
| OG001 | Asenapine/Asenapine | Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension |
| OG002 | Haloperidol/Haloperidol | Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension |
|
|
|
| Primary | Median Survival Time of Effect | Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy. | These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension. | Posted | Median | 95% Confidence Interval | Days | 52 Weeks |
|
|
|
| 12 |
| 50 |
| 28 |
| 50 |
| EG001 | Asenapine/Asenapine | Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension | 13 | 92 | 54 | 92 |
| EG002 | Haloperidol/Haloperidol | Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension | 6 | 43 | 25 | 43 |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| HYPONATREMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| SCHIZOPHRENIA, PARANOID TYPE | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
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| HYPOAESTHESIA ORAL | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (10.1) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
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| WEIGHT INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
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| AKATHISIA | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| PARKINSONISM | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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Except for compelling legal reasons, neither the sponsor nor the investigator will communicate to third parties any result of the clinical trial before the CTR has been released by the sponsor.