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

Last updated: October 19, 2020
Sponsor: Noven Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Psychosis

Tourette's Syndrome

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02876900
HP-3070-GL-04
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current diagnosis of schizophrenia.

  • Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of thefollowing PANSS items at Screening and at Baseline: conceptual disorganizationdelusions; hallucinatory behavior; unusual thought content.

  • Subjects must be able to wear a transdermal patch for 24 hours.

Exclusion

Exclusion Criteria:

  • Subject has been diagnosed with schizophrenia less than 6 months prior to ScreeningVisit.

  • Subject has received within 90 days of Screening Visit: electroconvulsive therapy;transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulationtreatments

  • Subject has experienced acute depressive symptoms within 30 days prior to ScreeningVisit that requires treatment with an antidepressant, as determined by theInvestigator.

  • 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.

Study Design

Total Participants: 617
Study Start date:
August 01, 2016
Estimated Completion Date:
June 30, 2018

Study 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.

Connect with a study center

  • Noven Pharmaceuticals, Inc.

    Jersey City, New Jersey 07310
    United States

    Site Not Available

  • Noven Pharmaceuticals, Inc.

    New York, New York 10118
    United States

    Site Not Available

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