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This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
This is a Phase 3, randomized, double-blind, placebo-controlled, in-patient, efficacy, and safety study to evaluate HP-3070 for the treatment of schizophrenia.
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation, using a population-based approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Asenapine maleate patch | Experimental | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. |
|
| High dose asenapine maleate patch | Experimental | High dose asenapine maleate, transdermal patches will be compared against placebo patches. |
|
| Placebo transdermal patch | Placebo Comparator | Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Asenapine maleate transdermal patch | Drug | The study will evaluate low dose Asenapine maleate transdermal patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6. | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6. | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale. The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Harb, MD, MPH | Noven Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Jersey City | New Jersey | 07310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35687858 | Derived | Citrome L, Komaroff M, Starling B, Byreddy S, Terahara T, Hasebe M. Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study. J Clin Psychiatry. 2022 Jun 6;83(4):21m14355. doi: 10.4088/JCP.21m14355. | |
| 33326711 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Asenapine Maleate Patch | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch. Placebo: Evaluate Low Dose versus Placebo. |
| FG001 | High Dose Asenapine Maleate Patch | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: Evaluate High Dose versus Placebo. |
| FG002 | Placebo Patch | Placebo transdermal patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 616 subjects were randomized in the double-blind treatment period of the study and were included in the Intent-to-Treat (ITT) analysis set (206 patients in HP-3070 18.0 mg group, 204 patients in HP-3070 9.0 mg group, 206 patients in placebo group). One additional subject met exclusion criteria for the study but was not dosed (n=617).
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Asenapine Maleate Patch | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6. | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity. | Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
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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 | Low Dose Asenapine Maleate Patch | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MeDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | MeDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Harb, MD, MPH - Executive Director, Clinical Development | Noven Pharmaceuticals | 1-551-233-2656 | gharb@noven.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2016 | Feb 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2018 | Feb 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| High Dose Asenapine maleate transdermal patch | Drug | The study will evaluate high dose Asenapine maleate transdermal patch |
|
|
| Placebo | Drug | The study will evaluate placebo transdermal patch. |
|
|
| 6 weeks |
| Citrome L, Walling DP, Zeni CM, Starling BR, Terahara T, Kuriki M, Park AS, Komaroff M. Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2020 Dec 15;82(1):20m13602. doi: 10.4088/JCP.20m13602. |
| High Dose Asenapine Maleate Patch |
High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. |
| BG002 | Placebo Patch | Placebo transdermal patch |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| PANSS total score | Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items & 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Low Dose Asenapine Maleate Patch | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. |
| OG001 | High Dose Asenapine Maleate Patch | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. |
| OG002 | Placebo Patch | Placebo transdermal patch |
|
|
|
| Secondary | Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6. | To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale. The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. | Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 0 |
| 204 |
| 3 |
| 204 |
| 75 |
| 204 |
| EG001 | High Dose Asenapine Maleate Patch | High dose asenapine maleate, transdermal patches will be compared against placebo patches. High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch Placebo: The study will evaluate placebo transdermal patch. | 0 | 204 | 2 | 204 | 78 | 204 |
| EG002 | Placebo | Placebo transdermal patch | 0 | 206 | 4 | 206 | 70 | 206 |
| Overdose | Injury, poisoning and procedural complications | MeDRA (20.1) | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | MeDRA (20.1) | Systematic Assessment |
|
| Gastrointestinal ulcer hemorrhage | Gastrointestinal disorders | MeDRA (20.1) | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MeDRA (20.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MeDRA (20.1) | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MeDRA (20.1) | Systematic Assessment |
|
| Application site erythema | General disorders | MeDRA (20.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MeDRA (20.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MeDRA (20.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MeDRA (20.1) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MeDRA (20.1) | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| >=90 |
|
| Superiority |
| The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom. | Mixed Model Repeated Measures Analysis | <0.001 | Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure. | Least Square Mean Difference | -0.4 | Standard Error of the Mean | 0.099 | 2-Sided | 95 | -0.64 | -0.25 | Superiority |