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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noven Pharmaceuticals, Inc.
• Treatments: Asenapine; Maleic acid

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.