- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190267
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
February 7, 2022 updated by: Organon and Co
A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia.
This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897.
Participants in this extension study will receive open-label asenapine for 26 weeks.
Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
- Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator's judgment, would benefit from long-term treatment.
- Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.
Exclusion Criteria:
- A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
- A participant must not be at imminent risk of self-harm or harm to others.
- A participant must not currently be under involuntary inpatient commitment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asenapine
All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigator's discretion).
Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigator's discretion, based on tolerability and/or symptomatology.
|
asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study
Time Frame: Up to 30 weeks
|
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
An AE was defined as a "treatment-emergent" AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.
|
Up to 30 weeks
|
Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE
Time Frame: Up to 26 weeks
|
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Up to 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2010
Primary Completion (Actual)
October 7, 2013
Study Completion (Actual)
October 7, 2013
Study Registration Dates
First Submitted
August 25, 2010
First Submitted That Met QC Criteria
August 25, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05897
- 2009-018038-12 (EudraCT Number)
- MK-8274-021 (Other Identifier: Merck Research Laboratories)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia, Paranoid
-
Mental Health Services in the Capital Region, DenmarkCentral Denmark Region; Mental Health Services in the North Denmark RegionActive, not recruitingPsychotic Disorders | Schizophrenia and Related Disorders | Schizotypal Disorder | Schizophrenia Prodromal | Paranoid Schizophrenia | Paranoid Ideation | Paranoid Delusion | Ideas of Reference | Psychosis Paranoid | Psychotic Paranoia | Psychotic; Disorder, DelusionalDenmark
-
Merck Sharp & Dohme LLCCompletedSchizophrenia | Paranoid Schizophrenia
-
Merck Sharp & Dohme LLCCompletedParanoid Schizophrenia
-
Weill Medical College of Cornell UniversityNational Alliance for Research on Schizophrenia and DepressionCompleted
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
CEDIARA - Assoc. Solidariedade Social de Ribeira...CompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Delusional Disorder | Substance-Induced Psychotic DisorderPortugal
-
Weill Medical College of Cornell UniversityCompletedSchizophrenia | Delusional DisorderUnited States
-
King's College LondonCompletedParanoia | Schizophrenia-spectrum DiagnosisUnited Kingdom
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Odense Patient Data Explorative NetworkCompletedSchizophrenia, Schizotypal and Delusional DisordersDenmark
-
German Research FoundationUnknownSchizophrenia | Delusional Disorders (ICD-10)Germany
Clinical Trials on asenapine
-
Organon and CoCompleted
-
Lori Davis, MDMerck Sharp & Dohme LLC; Forest LaboratoriesCompletedAn Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress DisorderPosttraumatic Stress DisorderUnited States
-
Organon and CoCompleted
-
Duke UniversityMerck Sharp & Dohme LLCCompleted
-
Organon and CoCompleted
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompleted
-
Amneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Completed
-
Organon and CoCompleted