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Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia. (HP-3070)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Low Dose Asenapine maleate transdermal patch
High Dose Asenapine maleate transdermal patch
Placebo
Sponsored by
Noven Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Noven Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose Asenapine maleate patch

High dose asenapine maleate patch

Placebo transdermal patch

Arm Description

Low dose asenapine maleate, transdermal patches will be compared against placebo patches.

High dose asenapine maleate, transdermal patches will be compared against placebo patches.

Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2016
Last Updated
October 19, 2020
Sponsor
Noven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02876900
Brief Title
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Acronym
HP-3070
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noven Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose Asenapine maleate patch
Arm Type
Experimental
Arm Description
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Arm Title
High dose asenapine maleate patch
Arm Type
Experimental
Arm Description
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
Arm Title
Placebo transdermal patch
Arm Type
Placebo Comparator
Arm Description
Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches
Intervention Type
Drug
Intervention Name(s)
Low Dose Asenapine maleate transdermal patch
Other Intervention Name(s)
Transdermal patch
Intervention Description
The study will evaluate low dose Asenapine maleate transdermal patch
Intervention Type
Drug
Intervention Name(s)
High Dose Asenapine maleate transdermal patch
Other Intervention Name(s)
Transdermal patch
Intervention Description
The study will evaluate high dose Asenapine maleate transdermal patch
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sham treatment
Intervention Description
The study will evaluate placebo transdermal patch.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Harb, MD, MPH
Organizational Affiliation
Noven Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Noven Pharmaceuticals, Inc.
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07310
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35687858
Citation
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.
Results Reference
derived
PubMed Identifier
33326711
Citation
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.
Results Reference
derived

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

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