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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT02876900

Run by

Noven Pharmaceuticals, Inc.

People needed

617

Starts

2016-08-01

Expected to finish

2018-06-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Noven Pharmaceuticals, Inc. — Jersey City, New Jersey, United States

Full record on ClinicalTrials.gov

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