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SchizophreniaPhase 3PALMFlexSNCT01281527

Paliperidone Palmitate Flexible Dosing in Schizophrenia

A Phase 3 study testing Paliperidone Palmitate in people with Schizophrenia, run by Janssen-Cilag International NV at 127 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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 Palmitate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,044 participants
Where
127 sitesin 20 countries
Study dates
Nov 2010to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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

Trial locations and contacts

127 sites in 20 countries.

127 sites in 20 countries

Germany18 sites

  • Study site

    Bad Saarow

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Bochum

  • Study site

    Butzbach

  • Study site

    Dresden

  • Study site

    Gelsenkirchen

  • Study site

    Greifswald

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Königsbrück

  • Study site

    Mittweida

  • Study site

    Oranienburg

  • Study site

    Regensburg

  • Study site

    Stralsund

  • Study site

    Ulm

  • Study site

    Westerstede

  • Study site

    Würzburg

Other trials in Germany

France15 sites

  • Study site

    Bar-le-Duc

  • Study site

    Bron

  • Study site

    Clermont-Ferrand

  • Study site

    Dax

  • Study site

    Dijon

  • Study site

    Dole

  • Study site

    Lille

  • Study site

    Limoges

  • Study site

    Montpellier

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Saint-Nazaire

  • Study site

    Saint-Priest-en-Jarez

  • Study site

    Strasbourg

  • Study site

    Villejuif

Other trials in France

Spain15 sites

  • Study site

    Alcorcón

  • Study site

    Alicante

  • Study site

    Barcelona

  • Study site

    Burgos

  • Study site

    Coslada

  • Study site

    Elche

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Palma de Mallorca

  • Study site

    Sant Boi de Llobregat

  • Study site

    Sant Joan d'Alacant

  • Study site

    Santa Coloma de Gramenet

  • Study site

    Vigo

  • Study site

    Zamora

  • Study site

    Zaragoza

Other trials in Spain

Ukraine14 sites

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Hlevakha

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Simferopol

  • Study site

    Smila

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Yevpatoriya

Other trials in Ukraine

Belgium9 sites

  • Study site

    Brussels

  • Study site

    Dave

  • Study site

    Diest

  • Study site

    Kruishoutem

  • Study site

    Liège

  • Study site

    Melle

  • Study site

    Roeselare

  • Study site

    Sint-Denijs-Westrem

  • Study site

    Tournai

Other trials in Belgium

United Kingdom9 sites

  • Study site

    Barnet

  • Study site

    Birmingham

  • Study site

    Cambridge

  • Study site

    Coventry

  • Study site

    Darlington

  • Study site

    Lincoln

  • Study site

    London

  • Study site

    Prescott

  • Study site

    Stoke-on-Trent

Other trials in United Kingdom

Latvia6 sites

  • Study site

    Daugavpils

  • Study site

    Jelgava

  • Study site

    Liepāja

  • Study site

    Riga

  • Study site

    Sigulda

  • Study site

    Strenči

Other trials in Latvia

Portugal6 sites

  • Study site

    Almada

  • Study site

    Angra do Heroísmo

  • Study site

    Castelo Viegas

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Sweden6 sites

  • Study site

    Gothenburg

  • Study site

    Lidingö

  • Study site

    Malmö

  • Study site

    Mölndal

  • Study site

    Spånga

  • Study site

    Upplands Vasby

Other trials in Sweden

Turkey (Türkiye)6 sites

  • Study site

    Ankara

  • Study site

    Diyarbakır

  • Study site

    Gaziantep

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Trabzon

Other trials in Turkey (Türkiye)

Greece5 sites

  • Study site

    Arta

  • Study site

    Athens

  • Study site

    Katerini

  • Study site

    Thessaloniki

  • Study site

    Thessalonikis

Other trials in Greece

Denmark3 sites

  • Study site

    Aalborg

  • Study site

    København V

  • Study site

    Randers

Other trials in Denmark

Hungary3 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Pécs

Other trials in Hungary

Israel3 sites

  • Study site

    Pardesiyya

  • Study site

    Ramat Gan

  • Study site

    Tirat Hacarmel

Other trials in Israel

Croatia2 sites

  • Study site

    Rijeka

  • Study site

    Zagreb

Other trials in Croatia

Lithuania2 sites

  • Study site

    Panevezys

  • Study site

    Vilnius

Other trials in Lithuania

Switzerland2 sites

  • Study site

    Solothurn

  • Study site

    Zurich

Other trials in Switzerland

Austria1 site

  • Study site

    Salzburg

Other trials in Austria

Estonia1 site

  • Study site

    Tallinn

Other trials in Estonia

Netherlands1 site

  • Study site

    Groningen

Other trials in Netherlands

About this study

Official title: 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

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.

Read the 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
Being tested
Paliperidone Palmitate
Keywords
Paliperidone palmitate, Schizophrenia, Intramuscular injection
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paliperidone PalmitateDrug

    50 - 150 mg eq. every 30 days

Study groups in NCT01281527
Study groupRoleWhat they receive
Paliperidone PalmitateExperimentalPaliperidone 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)
Receives: Drug: Paliperidone Palmitate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline.

    Measured: Baseline to 6 months or early discontinuation

  2. Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline.

    Measured: Baseline to 6 months or early discontinuation

  3. Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline.

    Measured: Baseline to 6 months or early discontinuation

Secondary outcomes (5)

  1. Change from baseline in Clinical Global Impression-Severity Scale [CGI-S]

    Measured: Baseline, week 1, month 1, 2, 3 and 6

  2. Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP])

    Measured: Baseline, week 1, month 1, 2, 3 and 6

  3. Change from baseline in Health status (Self-reported health status questionnaire [SF-36])

    Measured: Baseline, month 3 and 6

  4. Change from baseline in Measure of Health Outcome (EQ-5D)

    Measured: Baseline, month 3 and 6

  5. Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]);

    Measured: Baseline, month 3 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2012
  4. Study completionNov 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01281527
Sponsor's protocol ID
CR017215
Other IDs
R092670SCH3010
Acronym
PALMFlexS
Status last verified
Mar 2014
First submitted
20 Jan 2011
Last updated
10 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25444566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paliperidone Palmitate in people with Schizophrenia, run by Janssen-Cilag International NV at 127 sites in 20 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 1 inclusion and 1 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Germany, France, Spain, Ukraine, Belgium and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline. (time frame: Baseline to 6 months or early discontinuation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01281527, which also lists 1 linked publication.

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 10 Mar 2014.

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