An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
Information source: Janssen-Cilag International NV
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone ER (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Janssen-Cilag International NV Official(s) and/or principal investigator(s): Janssen-Cilag International NV Clinical Trial, Study Director, Affiliation: Janssen-Cilag International NV
Summary
The purpose of this study is to explore tolerability, safety and effectiveness of flexibly
dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric
disorder with symptoms of emotional instability, detachment from reality, often with
delusions and hallucinations, and withdrawal into the self) previously unsuccessfully
treated with an oral antipsychotic medication.
Clinical Details
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score in Those Participants who Transitioned due to Lack of EfficacyChange From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
Secondary outcome: Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) ScoreChange From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26) Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Endpoint (up to Week 26) Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26) Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26) Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26) Number of Participants With Satisfaction With the Study Treatment Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26) Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
Detailed description:
This is a non-randomized (the study drug is not assigned by chance), single arm, multicenter
(when more than one hospital or medical school team work on a medical research study)
6-month study. Participants can be transitioned to an effective dose of paliperidone ER from
any oral antipsychotic medication due to lack of efficacy, lack of tolerability or safety,
lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed.
Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of
paliperidone once daily orally for 6 months. Adjustment of the dosage will be done at
Investigator's discretion, based on the individual participant's clinical response and
tolerability of the study drug dosages. Participants who complete this 6-month study and
would like to continue will be eligible to be enrolled in an extension phase until
paliperidone ER is available. The starting dose of the extension phase will be the same as
at the end of the 6-month study and may be changed throughout the extension period. The
extension phase will consist of a main extension phase (ending with an End of Main Extension
Phase Visit) and a modified extension phase (ending with an End of Study Visit). Efficacy
will primarily be evaluated by positive and negative syndrome scale (PANSS). Safety will
primarily be evaluated by Extrapyramidal Symptom Rating Scale (ESRS).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant meets the Diagnostic and Statistical Manual of Mental Disorders (Edition
4) criteria for schizophrenia
- Participant is previously non-acute (on the same antipsychotic medication used for
the treatment of schizophrenia and Clinical Global Impression-Severity [CGI-S] change
less than or equal to 1 in the past 4 weeks before enrollment) 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 effectiveness, lack of tolerability or safety,
lack of compliance and/or other reasons to switch to another antipsychotic medication
- Participant is healthy on the basis of a physical examination and vital signs at
screening
- Female participants 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
- Participants must be willing and able to fill out self-administered questionnaires
Exclusion Criteria:
- Participants on clozapine, any conventional depot neuroleptic or risperidone
long-acting injection during the last 3 months
- Participants with serious unstable medical condition, including known clinically
relevant laboratory abnormalities
- Participants with history or current symptoms of tardive dyskinesia (twitching or
jerking movements that you cannot control in your face, tongue, or other parts of
your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking,
confusion, sweating more than usual, increased heart rate or blood pressure, or
muscle pain or weakness)
- Participants judged to be at high risk for adverse events, violence or self-harm
- Participants with a current use or known history (over the past 6 months) of
substance dependence according to Diagnostic and Statistical Manual of Mental
Disorders (Edition 4) Criteria
Locations and Contacts
Antwerpen, Belgium
Bertrix, Belgium
Dave, Belgium
Diest, Belgium
Duffel, Belgium
Kortenberg, Belgium
Liège, Belgium
Montignies-Sur-Sambre, Belgium
Mortsel, Belgium
Roeselare, Belgium
Saint-Servais, Belgium
Sint-Truiden, Belgium
St Denijs-Westrem, Belgium
Tielt, Belgium
Waregem, Belgium
Bulgaria, Bulgaria
Sofia N/A, Bulgaria
Tzerova Korya, Bulgaria
Osijek, Croatia
Rijeka, Croatia
Split, Croatia
Zagreb, Croatia
Aalborg, Denmark
Helsingør, Denmark
Risskov N/A, Denmark
Viby J, Denmark
Helsinki, Finland
Raahe, Finland
Tammisaari, Finland
Tampere, Finland
Bar Le Duc, France
Bordeaux, France
Bourg En Bresse, France
Bully Les Mines, France
Caen, France
Chambery, France
Clermont Ferrand Cedex 1, France
Creteil Cedex, France
Dijon Cedex, France
Dole, France
Henin Baumont, France
Jarnac, France
La Roche Sur Yon, France
La Seyne Sur Mer, France
Mont St Martin, France
Montpellier, France
Nimes Cedex 9, France
Paris, France
Pau, France
Rennes, France
Roubaix, France
Saint Avé, France
Saint-Cyr Au Mont D'Or N/A, France
Villejuif Cedex, France
Aalen, Germany
Achim, Germany
Augsburg, Germany
Bamberg, Germany
Bergfelde, Germany
Berlin, Germany
Bochum, Germany
Butzbach, Germany
Coesfeld, Germany
Dillingen, Germany
Dresden, Germany
Duisburg, Germany
Düsseldorf, Germany
Ellwangen, Germany
Elmshorn, Germany
Ettlingen, Germany
Gelnhausen, Germany
Gelsenkirchen, Germany
Gießen, Germany
Göttingen, Germany
Halle, Germany
Hamburg, Germany
Hattingen, Germany
Hemmoor, Germany
Heppenheim, Germany
Idar-Oberstein, Germany
Jena, Germany
Kaufbeuren, Germany
Krefeld, Germany
Köln, Germany
Königsbrück, Germany
Leipzig, Germany
Lüdenscheid, Germany
Mannheim, Germany
Meckel, Germany
Mittweida, Germany
München, Germany
Münster, Germany
Norden, Germany
Nürnberg, Germany
Ober-Ramstadt, Germany
Oldenburg, Germany
Oranienburg, Germany
Ostfildern, Germany
Potsdam, Germany
Schlüchtern, Germany
Siegen, Germany
Stralsund, Germany
Straubing, Germany
Ulm, Germany
Wasserburg, Germany
Wiesbaden, Germany
Wilhelmshaven, Germany
Würzburg, Germany
Athens, Greece
Chios, Greece
Herakleion, Greece
Larisa, Greece
Thessalonikis, Greece
Balassagyarmat N/A, Hungary
Budapest N/A, Hungary
Kecskemet, Hungary
Sopron, Hungary
Bat-Yam, Israel
Be'Er Ya'Acov, Israel
Jerusalem, Israel
Pardesia, Israel
Daugavpils, Latvia
Jelgava, Latvia
Liepaja, Latvia
Riga, Latvia
Strenci, Latvia
Kaunas, Lithuania
Panevezys, Lithuania
Vilnius, Lithuania
'S-Gravenhage, Netherlands
Assen, Netherlands
Beilen, Netherlands
Bennebroek, Netherlands
Enschede, Netherlands
Groningen, Netherlands
Hoofddorp, Netherlands
Leeuwarden, Netherlands
Tilburg, Netherlands
Zwolle, Netherlands
Bydgoszcz N/A, Poland
Gdynia Na, Poland
Krakow Na, Poland
Lubliniec, Poland
Skorzewo Na, Poland
Angra Do Heroísmo, Portugal
Braga, Portugal
Castelo Viegas N/A, Portugal
Coimbra, Portugal
Lisboa N/A, Portugal
Lisboa, Portugal
Porto N/A, Portugal
Porto, Portugal
Kazan, Russian Federation
Krasnodar, Russian Federation
Moscow N/A, Russian Federation
Moscow Russia, Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Saratov, Russian Federation
St Peterburg Na, Russian Federation
St Petersburg, Russian Federation
Yaroslavl, Russian Federation
Beograd, Serbia
Kragujevac, Serbia
Novi Sad, Serbia
Alicante, Spain
Barcelona, Spain
Bunyola Illes Balears, Spain
Burgos, Spain
Oviedo, Spain
Pontevedra, Spain
Sama De Langreo Asturias, Spain
Valencia, Spain
Zamora, Spain
Zaragoza, Spain
Bromma, Sweden
Göteborg, Sweden
Hudiksvall, Sweden
Karlskrona, Sweden
Malmö, Sweden
Mölndal, Sweden
Norrtälje, Sweden
Nyköping, Sweden
Simrishamn, Sweden
Skövde, Sweden
Solna, Sweden
Trollhättan, Sweden
Västra Frölunda, Sweden
Aarau, Switzerland
Basel Bs, Switzerland
Bienne, Switzerland
Geneve, Switzerland
Lenzburg, Switzerland
Montreux, Switzerland
Oetwil Am See, Switzerland
Riehen, Switzerland
Solothurn, Switzerland
Viganello, Switzerland
Zürich, Switzerland
Ankara N/A, Turkey
Denizli, Turkey
Diyarbakir, Turkey
Gaziantep, Turkey
Izmir, Turkey
Barnet, United Kingdom
Birmingham, United Kingdom
Clacton On Sea, United Kingdom
Devon, United Kingdom
Exeter, United Kingdom
Glasgow, United Kingdom
Additional Information
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Starting date: April 2007
Last updated: July 1, 2015
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