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Completed

NCT Number: NCT02876900

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Noven Pharmaceuticals, Inc.

Jersey City, New Jersey, 07310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Dose Asenapine maleate transdermal patch

Drug

The study will evaluate low dose Asenapine maleate transdermal patch

Other names: Transdermal patch

High Dose Asenapine maleate transdermal patch

Drug

The study will evaluate high dose Asenapine maleate transdermal patch

Other names: Transdermal patch

Placebo

Drug

The study will evaluate placebo transdermal patch.

Other names: Sham treatment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Noven Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: HP-3070

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2016
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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