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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 Efficacy

Change 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) Score

Change 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

Page last updated: August 23, 2015

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