Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, 6-Week, In-Patient Study to Assess Efficacy and Safety of HP-3070 in Subjects Diagnosed With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Low Dose Asenapine maleate transdermal patch
* Drug: High Dose Asenapine maleate transdermal patch
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current diagnosis of schizophrenia. Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the following PANSS items at Screening and at Baseline: conceptual disorganization delusions; hallucinatory behavior; unusual thought content. Subjects must be able to wear a transdermal patch for 24 hours. Exclusion Criteria: Subject has been diagnosed with schizophrenia less than 6 months prior to Screening Visit. Subject has received within 90 days of Screening Visit: electroconvulsive therapy; transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation treatments Subject has experienced acute depressive symptoms within 30 days prior to Screening Visit that requires treatment with an antidepressant, as determined by the Investigator. Currently taking clozapine for the treatment of schizophrenia. Has hypothyroidism or hyperthyroidism. Subject is currently being treated with insulin for diabetes. Subject has epilepsy or history of seizures. Positive urine pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose Asenapine maleate patch<br>Low dose asenapine maleate, transdermal patches will be compared against placebo patches. | Drug: Low Dose Asenapine maleate transdermal patch<br>* The study will evaluate low dose Asenapine maleate transdermal patch<br>* Other names: Transdermal patch;Drug: Placebo<br>* The study will evaluate placebo transdermal patch.<br>* Other names: Sham treatment;|
| Experimental: High dose asenapine maleate patch<br>High dose asenapine maleate, transdermal patches will be compared against placebo patches. | Drug: High Dose Asenapine maleate transdermal patch<br>* The study will evaluate high dose Asenapine maleate transdermal patch<br>* Other names: Transdermal patch;Drug: Placebo<br>* The study will evaluate placebo transdermal patch.<br>* Other names: Sham treatment;|
| Placebo Comparator: Placebo transdermal patch<br>Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches | Drug: Placebo<br>* The study will evaluate placebo transdermal patch.<br>* Other names: Sham treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 6 weeks |