SchizophreniaPhase 3NCT01142596

Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)

A Phase 3 study testing Asenapine in people with Schizophrenia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: Asenapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: No sites listed yet
Study dates: 25 May 2010to 22 Apr 2015
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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.

Who cannot join

A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
A participant must not be at risk of harming themselves or others, in the investigator's opinion;
A participant must not have been determined to be unsuitable by an investigator.

About this study

Official title: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)

This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124 [NCT01098110]), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After re-randomization, drug will be administered open-label for 46 weeks. During this period dose is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability.

Conditions: Schizophrenia
Being tested: Asenapine, Placebo
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AsenapineDrug
Also called SCH 900274
Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID
PlaceboDrug
Placebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)

Study groups in NCT01142596
Study group	Role	What they receive
Asenapine 5 mg BID	Experimental	Participants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg BID at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability Receives: Drug: Asenapine; Drug: Placebo
Asenapine 10 mg BID	Experimental	Participants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg bid at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability Receives: Drug: Asenapine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment
For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.
Measured: Study P06124 baseline and P06125 study from Day 1 up to Week 52
Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment
For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.
Measured: Study P06125 baseline up to Week 52
Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52
For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06124 baseline and study P06125 Week 52
Change From Study P06125 Baseline in BMI at Week 52
For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06125 baseline and Week 52
Number of Participants With Extrapyramidal Symptoms
This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "extrapyramidal syndrome" were treated as extrapyramidal symptoms.
Measured: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint
Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.
Measured: Study P06124 baseline and P06125 study from Day 1 up to Week 52
Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint
Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.
Measured: Study P06125 baseline up to Week 52
Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint
Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.
Measured: Study P06124 baseline and P06125 study from Day 1 up to Week 52
Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint
Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.
Measured: Study P06125 baseline up to Week 52
Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06124 baseline and study P06125 Week 52
Change From Study P06125 Baseline in HbA1c at Week 52
For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06125 baseline and Week 52
Change From Study P06124 Baseline in Fasting Glucose at Week 52
For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06124 baseline and study P06125 Week 52
Change From Study P06125 Baseline in Fasting Glucose at Week 52
For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06125 baseline and Week 52
Change From Study P06124 Baseline in Insulin at Week 52
For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06124 baseline and study P06125 Week 52
Change From Study P06125 Baseline in Insulin at Week 52
For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06125 baseline and Week 52
Change From Study P06124 Baseline in Prolactin at Week 52
For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06124 baseline and study P06125 Week 52
Change From Study P06125 Baseline in Prolactin at Week 52
For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Measured: Study P06125 baseline and Week 52
Number of Participants With Serious Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
Number of Participants With Non-serious AEs
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).
Measured: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52
The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.
Measured: Study P06124 baseline and P06125 study baseline and Week 52
Number of Participants Who Took Antiparkinsonian Drugs
This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.
Measured: P06125 study from Day 1 up to Week 52
Median Time to Loss of Effect in Responders
Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.
Measured: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52
Median Time to Loss of Effect in Non-Responders
Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.
Measured: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201022 Apr 2015

First posted11 Jun 2010 (estimated)
Study start25 May 2010
Primary completion22 Apr 2015
Study completion22 Apr 2015

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 (1)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01142596
Sponsor's protocol ID: P06125
Other IDs: 132324
Status last verified: Feb 2022
First submitted: 10 Jun 2010
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kinoshita T, Takekita Y, Hiraoka S, Tamura F, Iwama Y. Long-term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow-up for 52 weeks (P06125)-Secondary publication. Neuropsychopharmacol Rep. 2023 Sep;43(3):328-337. doi: 10.1002/npr2.12342. Epub 2023 May 25.
PubMed 37232002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Active, not recruiting
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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)
ClinicalTrials.gov ID: NCT01142596
Acronym / sponsor ID: P06125
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Meiji Seika Pharma Co., Ltd.
Study start: 25 May 2010 (actual)
Primary completion: 22 Apr 2015 (actual)
Study completion: 22 Apr 2015 (actual)
First posted: 11 Jun 2010 (estimated)
Results: Posted 18 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Asenapine 5 mg BID	Experimental	Drug: Asenapine, Drug: PlaceboParticipants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg BID at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
Asenapine 10 mg BID	Experimental	Drug: Asenapine, Drug: PlaceboParticipants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg bid at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.

Key exclusion criteria (5 listed)

A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
A participant must not be at risk of harming themselves or others, in the investigator's opinion;
A participant must not have been determined to be unsuitable by an investigator.

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
AsenapineAlso: SCH 900274Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID	Drug	Asenapine 10 mg BID, Asenapine 5 mg BID
PlaceboPlacebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)	Drug	Asenapine 10 mg BID, Asenapine 5 mg BID

Primary outcome

Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment
Time frame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.
Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment
Time frame: Study P06125 baseline up to Week 52
For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.
Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52
Time frame: Study P06124 baseline and study P06125 Week 52
For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Change From Study P06125 Baseline in BMI at Week 52
Time frame: Study P06125 baseline and Week 52
For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Number of Participants With Extrapyramidal Symptoms
Time frame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "extrapyramidal syndrome" were treated as extrapyramidal symptoms.
Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint
Time frame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.
Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint
Time frame: Study P06125 baseline up to Week 52
Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.
Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint
Time frame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.
Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint
Time frame: Study P06125 baseline up to Week 52
Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.
Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
Time frame: Study P06124 baseline and study P06125 Week 52
For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Change From Study P06125 Baseline in HbA1c at Week 52
Time frame: Study P06125 baseline and Week 52
For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Change From Study P06124 Baseline in Fasting Glucose at Week 52
Time frame: Study P06124 baseline and study P06125 Week 52
For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Change From Study P06125 Baseline in Fasting Glucose at Week 52
Time frame: Study P06125 baseline and Week 52
For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Change From Study P06124 Baseline in Insulin at Week 52
Time frame: Study P06124 baseline and study P06125 Week 52
For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Change From Study P06125 Baseline in Insulin at Week 52
Time frame: Study P06125 baseline and Week 52
For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Change From Study P06124 Baseline in Prolactin at Week 52
Time frame: Study P06124 baseline and study P06125 Week 52
For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).
Change From Study P06125 Baseline in Prolactin at Week 52
Time frame: Study P06125 baseline and Week 52
For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).
Number of Participants With Serious Adverse Events (AEs)
Time frame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Number of Participants With Non-serious AEs
Time frame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).
Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52
Time frame: Study P06124 baseline and P06125 study baseline and Week 52
The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.
Number of Participants Who Took Antiparkinsonian Drugs
Time frame: P06125 study from Day 1 up to Week 52
This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.
Median Time to Loss of Effect in Responders
Time frame: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52
Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.
Median Time to Loss of Effect in Non-Responders
Time frame: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52
Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.

Results and safety

Results posted to the registry on 18 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Asenapine	44	15
Asenapine 5/10 mg BID	157	71

Primary outcome: Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment

Time frame: Study P06124 baseline and P06125 study from Day 1 up to Week 52. Number. Unit: percentage of participants in category

Measure	Placebo/Asenapine n = 31	Asenapine 5/10 mg BID n = 138
Increase ≥7%	12.9	26.8
Change within ± 7%	64.5	61.6
Decrease ≥7%	22.6	11.6

Population analysed: All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 final assessment

Primary outcome: Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment

Time frame: Study P06125 baseline up to Week 52. Number. Unit: percentage of participants in category

Measure	Placebo/Asenapine n = 31	Asenapine 5/10 mg BID n = 138
Increase ≥7%	22.6	23.9
Change within ± 7%	64.5	62.3
Decrease ≥7%	12.9	13.8

Population analysed: All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and final assessment

Primary outcome: Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52

Time frame: Study P06124 baseline and study P06125 Week 52. Mean (Standard Deviation). Unit: kg/m^2

Measure	Placebo/Asenapine n = 15	Asenapine 5/10 mg BID n = 70
Value	-0.04 (2.83)	0.91 (2.74)

Population analysed: All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52

Primary outcome: Change From Study P06125 Baseline in BMI at Week 52

Time frame: Study P06125 baseline and Week 52. Mean (Standard Deviation). Unit: kg/m^2

Measure	Placebo/Asenapine n = 15	Asenapine 5/10 mg BID n = 70
Value	0.35 (2.48)	0.75 (2.41)

Population analysed: All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52

Adverse events

Time frame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Asenapine	5 of 44 (11.4%)	34 of 44 (77.3%)	Not reported
Asenapine 5/10 mg BID	32 of 157 (20.4%)	98 of 157 (62.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37232002Kinoshita T, Takekita Y, Hiraoka S, Tamura F, Iwama Y. Long-term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow-up for 52 weeks (P06125)-Secondary publication. Neuropsychopharmacol Rep. 2023 Sep;43(3):328-337. doi: 10.1002/npr2.12342. Epub 2023 May 25.
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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asenapine in people with Schizophrenia, run by Organon and Co.

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 5 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 18 May 2016). 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?

Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment (time frame: Study P06124 baseline and P06125 study from Day 1 up to Week 52). The study lists 23 primary outcomes in all. 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 NCT01142596, which also lists 1 linked publication.

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 28 May 2024.