SchizophreniaPhase 4PERFLEXNCT01724359
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
A Phase 4 study testing Paliperidone ER in people with Schizophrenia, run by Janssen-Cilag, S.A. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2008to Nov 2009
- Phase
- Phase 4
- 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
- Patient meets the criteria for schizophrenia
- Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Patient is healthy on the basis of a physical examination and vital signs at screening
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Who cannot join
- Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
- Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
- Patients judged to be at high risk for adverse events, violence, or self-harm
- Patients with known hypersensitivity to paliperidone ER or to risperidone
- Patients with a current use or known history (over the past 6 months) of substance dependence
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
About this study
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
Read the detailed description
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Paliperidone extended-release (ER), Antipsychotic agents
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone ER | Experimental | Not described Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Baseline, Week 26
Secondary outcomes (8)
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Measured: Baseline, Week 26
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Measured: Baseline, Week 26
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Measured: Baseline, Week 26
Clinical Global Impression-Severity (CGIS)
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
Measured: Baseline, Week 26
Personal and Social Performance (PSP) Scale
This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
Measured: Baseline, Week 26
Health Status as Measured by Self-rated Health Status Survey SF-36
The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.
Measured: Baseline, Week 26
Sleep Evaluation Scale
This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).
Measured: Baseline, Week 26
Daytime Drowsiness Evaluation Scale
This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startFeb 2008
- Primary completionNov 2009
- Study completionNov 2009
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.A. Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724359
- Sponsor's protocol ID
- CR017413
- Other IDs
- R076477SCH3029, R076477SCH3036
- Acronym
- PERFLEX
- Status last verified
- Feb 2013
- First submitted
- 7 Nov 2012
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT01724359
- Acronym / sponsor ID
- PERFLEX / CR017413
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone extended-release (ER), Antipsychotic agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Posted 15 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
Detailed description
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone ER | Experimental | Drug: Paliperidone ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient meets the criteria for schizophrenia
- Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Patient is healthy on the basis of a physical examination and vital signs at screening
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Key exclusion criteria (6 listed)
- Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
- Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
- Patients judged to be at high risk for adverse events, violence, or self-harm
- Patients with known hypersensitivity to paliperidone ER or to risperidone
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 |
|---|---|---|
| Paliperidone ERThe recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion. | Drug | Paliperidone ER |
Primary outcome
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
Time frame: Baseline, Week 26
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
8 secondary outcomes
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
Time frame: Baseline, Week 26
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
Time frame: Baseline, Week 26
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
Time frame: Baseline, Week 26
Clinical Global Impression-Severity (CGIS)
Time frame: Baseline, Week 26
Personal and Social Performance (PSP) Scale
Time frame: Baseline, Week 26
Health Status as Measured by Self-rated Health Status Survey SF-36
Time frame: Baseline, Week 26
Sleep Evaluation Scale
Time frame: Baseline, Week 26
Daytime Drowsiness Evaluation Scale
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen-Cilag S.A. Clinical Trial study director
Janssen-Cilag, S.A.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paliperidone ER in people with Schizophrenia, run by Janssen-Cilag, S.A. at 5 sites in 2 countries.
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 4 inclusion and 6 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Colombia, Argentina. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Mar 2013). 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?
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2013.