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

Noven Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: High Dose Asenapine maleate transdermal patch; Drug: Low Dose Asenapine maleate transdermal patch; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02876900

HP-3070-GL-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 617 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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617 participants in 3 patient groups, including a placebo group

Low dose Asenapine maleate patch

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Low Dose Asenapine maleate transdermal patch

High dose asenapine maleate patch

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: High Dose Asenapine maleate transdermal patch

Placebo transdermal patch

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo