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Trial record 65 of 3313 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT02876900
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
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, safety, and efficacy 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




Primary Outcome Measures :
  1. This study is designed to 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. [ 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.



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 York
Noven Pharmaceuticals, Inc.
New York, New York, United States, 10118
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Study Director: Yamina Merazga Noven Pharmaceuticals, Inc.

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Responsible Party: Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02876900     History of Changes
Other Study ID Numbers: HP-3070-GL-04
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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