SchizophreniaPhase 3HP-3070NCT02876900
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
A Phase 3 study testing Low Dose Asenapine maleate transdermal patch and High Dose Asenapine maleate transdermal patch in people with Schizophrenia, run by Noven Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Low Dose Asenapine maleate transdermal patch and High Dose Asenapine maleate transdermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 617 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Noven Pharmaceuticals, Inc.
Jersey City, New Jersey, 07310
About this study
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
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Low Dose Asenapine maleate transdermal patch, High Dose Asenapine maleate transdermal patch, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Asenapine maleate transdermal patchDrug
Also called Transdermal patch
The study will evaluate low dose Asenapine maleate transdermal patch
High Dose Asenapine maleate transdermal patchDrug
Also called Transdermal patch
The study will evaluate high dose Asenapine maleate transdermal patch
PlaceboDrug
Also called Sham treatment
The study will evaluate placebo transdermal patch.
| Study group | Role | What they receive |
|---|---|---|
| Low dose Asenapine maleate patch | Experimental | Low dose asenapine maleate, transdermal patches will be compared against placebo patches. Receives: 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale.
The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Harb, MD, MPH, Study director, Noven Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876900
- Sponsor's protocol ID
- HP-3070-GL-04
- Acronym
- HP-3070
- Status last verified
- Oct 2020
- First submitted
- 3 Aug 2016
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35687858Citrome 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.
PubMed 33326711
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02876900
- Acronym / sponsor ID
- HP-3070 / HP-3070-GL-04
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Noven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose Asenapine maleate patch | Experimental | Drug: Low Dose Asenapine maleate transdermal patch, Drug: PlaceboLow dose asenapine maleate, transdermal patches will be compared against placebo patches. |
| High dose asenapine maleate patch | Experimental | Drug: High Dose Asenapine maleate transdermal patch, Drug: PlaceboHigh dose asenapine maleate, transdermal patches will be compared against placebo patches. |
| Placebo transdermal patch | Placebo comparator | Drug: PlaceboLow dose or high dose asenapine maleate transdermal patch will be compared against placebo patches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Asenapine maleate transdermal patchAlso: Transdermal patchThe study will evaluate low dose Asenapine maleate transdermal patch | Drug | Low dose Asenapine maleate patch |
| High Dose Asenapine maleate transdermal patchAlso: Transdermal patchThe study will evaluate high dose Asenapine maleate transdermal patch | Drug | High dose asenapine maleate patch |
| PlaceboAlso: Sham treatmentThe study will evaluate placebo transdermal patch. | Drug | High dose asenapine maleate patch, Low dose Asenapine maleate patch, Placebo transdermal patch |
Primary outcome
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.
Time frame: 6 weeks
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.
1 secondary outcome
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.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35687858Citrome 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.
- Derived from this study: PubMed 33326711Citrome 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Harb, MD, MPH study director
Noven Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low Dose Asenapine maleate transdermal patch and High Dose Asenapine maleate transdermal patch in people with Schizophrenia, run by Noven Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02876900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.