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

NCT02876900 | Completed Phase 3 Results

• 1 other identifier: HP-3070-GL-04
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

  To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity.

  6 weeks

Secondary Outcomes (1)

• 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.

  6 weeks

Study Arms (3)

Low dose Asenapine maleate patch

EXPERIMENTAL

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

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

High dose asenapine maleate patch

EXPERIMENTAL

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

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

Placebo transdermal patch

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Low Dose Asenapine maleate transdermal patch DRUG

The study will evaluate low dose Asenapine maleate transdermal patch

Also known as: Transdermal patch

Low dose Asenapine maleate patch

High Dose Asenapine maleate transdermal patch DRUG

The study will evaluate high dose Asenapine maleate transdermal patch

Also known as: Transdermal patch

High dose asenapine maleate patch

Placebo DRUG

The study will evaluate placebo transdermal patch.

Also known as: Sham treatment

High dose asenapine maleate patch; Low dose Asenapine maleate patch; Placebo transdermal patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Noven Pharmaceuticals, Inc.: lead

Study Sites (1)

Noven Pharmaceuticals, Inc.

Jersey City, New Jersey, 07310, United States

Location

Related Publications (2)

• 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.

  PMID: 35687858 DERIVED

• 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.

  PMID: 33326711 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: George Harb, MD, MPH - Executive Director, Clinical Development
• Organization: Noven Pharmaceuticals

gharb@noven.com

1-551-233-2656

Study Officials

• George Harb, MD, MPH

  Noven Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 22, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)