Clinical trial NCT02876900: Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
measure: 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.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Noven Pharmaceuticals, Inc.
state: New Jersey
Study officials:
affiliation: Noven Pharmaceuticals, Inc.
name: George Harb, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Citrome L, Komaroff M, Starling B, Byreddy S, Terahara T, Hasebe M. 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. J Clin Psychiatry. 2022 Jun 6;83(4):21m14355. doi: 10.4088/JCP.21m14355.
citation: Citrome L, Walling DP, Zeni CM, Starling BR, Terahara T, Kuriki M, Park AS, Komaroff M. Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2020 Dec 15;82(1):20m13602. doi: 10.4088/JCP.20m13602.