Paliperidone Palmitate Flexible Dosing in Schizophrenia
PALMFlexS
A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics
2 other identifiers
interventional
1,044
19 countries
112
Brief Summary
This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Nov 2010
Typical duration for phase_3 schizophrenia
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMarch 10, 2014
March 1, 2014
2 years
January 20, 2011
March 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline.
Baseline to 6 months or early discontinuation
Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline.
Baseline to 6 months or early discontinuation
Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline.
Baseline to 6 months or early discontinuation
Secondary Outcomes (5)
Change from baseline in Clinical Global Impression-Severity Scale [CGI-S]
Baseline, week 1, month 1, 2, 3 and 6
Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP])
Baseline, week 1, month 1, 2, 3 and 6
Change from baseline in Health status (Self-reported health status questionnaire [SF-36])
Baseline, month 3 and 6
Change from baseline in Measure of Health Outcome (EQ-5D)
Baseline, month 3 and 6
Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]);
Baseline, month 3 and 6
Study Arms (1)
Paliperidone Palmitate
EXPERIMENTALPaliperidone Palmitate 50 - 150 mg eq. every 30 days for 6 months during the core phase and for 12 months during an optional extension phase after the last patient has completed the 6-month core treatment phase or until product will be available on market (whichever comes first)
Interventions
Eligibility Criteria
You may qualify if:
- Meet the DSM-IV criteria for schizophrenia Currently non-acute, i.e., on the same antipsychotic medication used for the treatment of schizophrenia given in an adequate dose and a CGI-S change \<= 1 in the past 4 weeks before enrollment Patient has been given an adequate dose of either an appropriate oral antipsychotic, or a protocol-defined LAI antipsychotic for an adequate period of time prior to enrollment, but current treatment is considered unsuccessful OR Patients with acute symptoms of schizophrenia, previously treated with an oral antipsychotic, having a baseline total Positive and Negative Syndrome Scale (PANSS) score \>= 80 and a baseline CGI-S score \>= 4 Women must be postmenopausal for at least 1 year, surgically sterile, abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control as local regulations permit, and before entry, must agree to continue to use the same method of contraception throughout the study Is cooperative and reliable, and agrees to receive regular injections and complete all aspects of the protocol Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
You may not qualify if:
- The patient's psychiatric diagnosis is due to direct pharmacological effects of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism) First antipsychotic treatment ever, i.e., patient has never been treated with antipsychotics before and antipsychotic treatment given in this study will be the first antipsychotic treatment that the patient will have ever received On clozapine during the last 3 months Patients who remain at imminent risk of suicide even after clinical intervention Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
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Salzburg, Austria
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Brussels, Belgium
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Dave, Belgium
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Diest, Belgium
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Kruishoutem, Belgium
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Liège, Belgium
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Melle, Belgium
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Roeselare, Belgium
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Sint-Denijs-Westrem, Belgium
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Tournai, Belgium
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Rijeka, Croatia
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Zagreb, Croatia
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Aalborg, Denmark
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København V, Denmark
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Randers, Denmark
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Tallinn, Estonia
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Bar-le-Duc, France
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Bron, France
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Clermont-Ferrand, France
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Dax, France
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Dijon, France
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Dole, France
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Lille, France
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Limoges, France
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Montpellier, France
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Nîmes, France
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Paris, France
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Saint-Nazaire, France
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Saint-Priest-en-Jarez, France
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Strasbourg, France
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Villejuif, France
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Bad Saarow, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Butzbach, Germany
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Dresden, Germany
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Gelsenkirchen, Germany
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Greifswald, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Königsbrück, Germany
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Mittweida, Germany
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Oranienburg, Germany
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Regensburg, Germany
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Stralsund, Germany
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Ulm, Germany
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Westerstede, Germany
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Würzburg, Germany
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Arta, Greece
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Athens, Greece
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Katerini, Greece
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Thessaloniki, Greece
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Thessalonikis, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Pardesiyya, Israel
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Ramat Gan, Israel
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Tirat Hacarmel, Israel
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Daugavpils, Latvia
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Jelgava, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Sigulda, Latvia
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Strenči, Latvia
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Panevezys, Lithuania
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Vilnius, Lithuania
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Groningen, Netherlands
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Almada, Portugal
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Angra do Heroísmo, Portugal
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Castelo Viegas, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Alcorcón, Spain
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Alicante, Spain
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Barcelona, Spain
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Burgos, Spain
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Coslada, Spain
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Elche, Spain
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Madrid, Spain
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Málaga, Spain
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Palma de Mallorca, Spain
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Sant Boi de Llobregat, Spain
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Sant Joan d'Alacant, Spain
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Santa Coloma de Gramenet, Spain
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Vigo, Spain
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Zamora, Spain
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Zaragoza, Spain
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Gothenburg, Sweden
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Lidingö, Sweden
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Malmo, Sweden
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Mölndal, Sweden
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Spånga, Sweden
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Upplands Vasby, Sweden
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Solothurn, Switzerland
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Zurich, Switzerland
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Gaziantep, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Trabzon, Turkey (Türkiye)
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Dnipro, Ukraine
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Donetsk, Ukraine
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Hlevakha, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Smila, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Yevpatoria, Ukraine
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Barnet, United Kingdom
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Coventry, United Kingdom
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Darlington, United Kingdom
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Lincoln, United Kingdom
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London, United Kingdom
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Prescott, United Kingdom
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Stoke-on-Trent, United Kingdom
Related Publications (1)
Schreiner A, Bergmans P, Cherubin P, Keim S, Rancans E, Bez Y, Parellada E, Carpiniello B, Vidailhet P, Hargarter L. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014 Oct 1;36(10):1372-88.e1. doi: 10.1016/j.clinthera.2014.08.014. Epub 2014 Oct 23.
PMID: 25444566DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 24, 2011
Study Start
November 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2013
Last Updated
March 10, 2014
Record last verified: 2014-03