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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876900
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : March 27, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics ( Noven Pharmaceuticals, Inc. )

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Low Dose Asenapine maleate transdermal patch Drug: High Dose Asenapine maleate transdermal patch Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Low dose Asenapine maleate patch
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Drug: Low Dose Asenapine maleate transdermal patch
The study will evaluate low dose Asenapine maleate transdermal patch
Other Name: Transdermal patch

Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Name: Sham treatment

Experimental: High dose asenapine maleate patch
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
Drug: High Dose Asenapine maleate transdermal patch
The study will evaluate high dose Asenapine maleate transdermal patch
Other Name: Transdermal patch

Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Name: Sham treatment

Placebo Comparator: Placebo transdermal patch
Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches
Drug: Placebo
The study will evaluate placebo transdermal patch.
Other Name: Sham treatment




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 weeks ]

    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 :
  1. 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. [ Time Frame: 6 weeks ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876900


Locations
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United States, New Jersey
Noven Pharmaceuticals, Inc.
Jersey City, New Jersey, United States, 07310
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Study Director: George Harb, MD, MPH Noven Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Noven Therapeutics ( Noven Pharmaceuticals, Inc. ):
Study Protocol  [PDF] January 20, 2016
Statistical Analysis Plan  [PDF] January 18, 2018

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Responsible Party: Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02876900    
Other Study ID Numbers: HP-3070-GL-04
First Posted: August 24, 2016    Key Record Dates
Results First Posted: March 27, 2020
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Asenapine
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs