Paliperidone Palmitate Flexible Dosing in Schizophrenia

NCT ID: NCT01281527

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1044 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

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.

Detailed Description

This study explores the tolerability, safety and treatment response of flexibly dosed paliperidone palmitate in approximately 1,000 patients with schizophrenia previously unsuccessfully treated with an oral or LAI antipsychotic medication. Non-acute and acute patients will be involved in the study. This study consists of a screening phase, a 6-month core treatment phase, and an optional extension phase. A transition period of preferably a maximum of 4 weeks will be allowed for the previous oral antipsychotic. When switching patients from previous LAI antipsychotics, paliperidone palmitate will be initiated in place of the next scheduled injection. Patients without source documentation of previous risperidone or paliperidone exposure must undergo oral tolerability testing with paliperidone ER (3 mg/day) for the 2 days prior to Baseline Visit. Patients who successfully complete the 6-month core treatment phase and would like to continue treatment with paliperidone palmitate may be enrolled in an optional extension phase until paliperidone palmitate is available in their respective country or until a maximum duration of 12 months after the last subject has completed the 6-month core treatment phase, whichever comes first. Patients will receive, without cost, paliperidone palmitate. Patients entering this optional extension phase, will receive once monthly injections with paliperidone palmitate. The recommended maintenance dose for these monthly injections is 75 mg eq. once monthly but flexible dosing in the range of 50 to 150 mg eq. once monthly will be allowed. The doctor may flexibly increase or decrease the dose preferably by one dosing level (within the range of 50 to 150 mg eq.) according to patients' clinical needs. During the extension phase, two types of visits can be distinguished: 'assessment visits' and 'treatment-only visits'. At each assessment visit (once every 3 months +/- 7 days), patients will receive their injection and will be questioned about adverse events (AEs). Body weight will also be assessed. Paliperidone palmitate will be given once monthly by injection in either the upper arm or buttocks muscle, but start every time with upper arm application. The recommended maintenance dose for these monthly injections is 75 mg eq., range could be between 50 to 150 mg eq.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Palmitate

Paliperidone 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)

Group Type: EXPERIMENTAL

Paliperidone Palmitate

Intervention Type: DRUG

50 - 150 mg eq. every 30 days

Interventions

Paliperidone Palmitate

50 - 150 mg eq. every 30 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Salzburg, , Austria

Brussels, , Belgium

Dave, , Belgium

Diest, , Belgium

Kruishoutem, , Belgium

Liège, , Belgium

Melle, , Belgium

Roeselare, , Belgium

Sint-Denijs-Westrem, , Belgium

Tournai, , Belgium

Rijeka, , Croatia

Zagreb, , Croatia

Aalborg, , Denmark

København V, , Denmark

Randers, , Denmark

Tallinn, , Estonia

Bar-le-Duc, , France

Bron, , France

Clermont-Ferrand, , France

Dax, , France

Dijon, , France

Dole, , France

Lille, , France

Limoges, , France

Montpellier, , France

Nîmes, , France

Paris, , France

Saint-Nazaire, , France

Saint-Priest-en-Jarez, , France

Strasbourg, , France

Villejuif, , France

Bad Saarow, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bochum, , Germany

Butzbach, , Germany

Dresden, , Germany

Gelsenkirchen, , Germany

Greifswald, , Germany

Hamburg, , Germany

Heidelberg, , Germany

Königsbrück, , Germany

Mittweida, , Germany

Oranienburg, , Germany

Regensburg, , Germany

Stralsund, , Germany

Ulm, , Germany

Westerstede, , Germany

Würzburg, , Germany

Arta, , Greece

Athens, , Greece

Katerini, , Greece

Thessaloniki, , Greece

Thessalonikis, , Greece

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Pardesiyya, , Israel

Ramat Gan, , Israel

Tirat Hacarmel, , Israel

Daugavpils, , Latvia

Jelgava, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Sigulda, , Latvia

Strenči, , Latvia

Panevezys, , Lithuania

Vilnius, , Lithuania

Groningen, , Netherlands

Almada, , Portugal

Angra do Heroísmo, , Portugal

Castelo Viegas, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Alcorcón, , Spain

Alicante, , Spain

Barcelona, , Spain

Burgos, , Spain

Coslada, , Spain

Elche, , Spain

Madrid, , Spain

Málaga, , Spain

Palma de Mallorca, , Spain

Sant Boi de Llobregat, , Spain

Sant Joan d'Alacant, , Spain

Santa Coloma de Gramenet, , Spain

Vigo, , Spain

Zamora, , Spain

Zaragoza, , Spain

Gothenburg, , Sweden

Lidingö, , Sweden

Malmo, , Sweden

Mölndal, , Sweden

Spånga, , Sweden

Upplands Vasby, , Sweden

Solothurn, , Switzerland

Zurich, , Switzerland

Ankara, , Turkey (Türkiye)

Diyarbakır, , Turkey (Türkiye)

Gaziantep, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Trabzon, , Turkey (Türkiye)

Dnipro, , Ukraine

Donetsk, , Ukraine

Hlevakha, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Simferopol, , Ukraine

Smila, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Yevpatoria, , Ukraine

Barnet, , United Kingdom

Birmingham, , United Kingdom

Cambridge, , United Kingdom

Coventry, , United Kingdom

Darlington, , United Kingdom

Lincoln, , United Kingdom

London, , United Kingdom

Prescott, , United Kingdom

Stoke-on-Trent, , United Kingdom

Countries

Austria; Belgium; Croatia; Denmark; Estonia; France; Germany; Greece; Hungary; Israel; Latvia; Lithuania; Netherlands; Portugal; Spain; Sweden; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 25444566 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=229&filename=CR017215_CSR.pdf

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

Other Identifiers

R092670SCH3010

Identifier Type: OTHER

Identifier Source: secondary_id

CR017215

Identifier Type: -

Identifier Source: org_study_id