Phase 3
Completed N=617
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Source: ClinicalTrials.gov NCT02876900 ↗Enrolled (actual)
617
Serious AEs
1.5%
Results posted
Mar 2020
Primary outcomePrimary: 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. — -22.1; -20.4; -15.5 score on a scale — p=0.003
◆ Published Evidence
Established
23citations · ~4 / year
Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study.
Summary
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
Linked Publications (2)
-
Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study.
-
Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-22.1; -20.4; -15.5 | 0.003 sig |
| SECONDARY 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. |
-1.3; -1.2; -0.9 | <0.001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02876900) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.