A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

May 26, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label, Long-Term, Multiple-Dose, Safety and Tolerability, Pharmacokinetic Study of 150 mg eq. Paliperidone Palmitate in the Treatment of Subjects With Schizophrenia

The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (identity and dose of study drug will be known to patients), safety and pharmacokinetic study of the highest dose (150 mg equivalent) of paliperidone palmitate (referred to as study drug) administered by intramuscular (IM) injection (injection into the muscle) in patients with schizophrenia. A total of at least 200 adult patients with schizophrenia will participate in the study. The study will consist of 2 phases: an up-to-21-day screening period and a 53-week open-label treatment period including an end of study/withdrawal visit. The total duration of the study will be approximately 56 weeks. At the screening visit, if a patient has been treated with an antipsychotic medication before study entry, the medication may be continued during the study except for protocol-specified medications that are not permitted. If patients have not received previous treatment with at least 2 oral (by mouth) doses of the antipsychotic agents risperidone or paliperidone or 1 dose of injectable RISPERDAL CONSTA or paliperidone palmitate, they will undergo a 4-day evaluation period and receive a 6 mg/day oral dose of an extended-release (ER) formulation of paliperidone to evaluate their ability to tolerate study drug. Patients who are able to tolerate study drug and meet all other entry criteria for the study will then be administered a single IM injection into the deltoid muscle (upper arm) of paliperidone palmitate 150 mg equivalent (eq) on Day 1 (Treatment A). Patients who tolerate Treatment A will receive a 2nd IM injection in the deltoid muscle of 150 mg eq on Day 8 followed by 150 mg eq administered by IM injection in the deltoid or gluteal (buttocks) muscle once every 4 weeks for the remainder of the 53-week treatment period. Patients who do not tolerate Treatment A or who do not wish to have multiple blood samples collected for pharmacokinetic testing will be assigned to Treatment B. Patients who do not tolerate Treatment A will receive a single IM injection of study drug 100 mg eq at their next scheduled visit followed by a flexible dose schedule of study drug ranging from 50 to 150 mg eq administered by IM injection in the deltoid or gluteal muscle every 4 weeks for the remainder of the 53-week treatment period. Blood samples for pharmacokinetics (ie, to test the concentration of study drug in the blood) will be collected at specified times before and after each dose of study drug from all patients; additional blood samples for pharmacokinetic testing will be collected from patients receiving Treatment A. An additional blood sample may also be collected at any time during screening or before the first day of IM administration of study drug for patients who agree to participate in an optional part of the study called a pharmacogenomic evaluation (genetic testing) for possible use in characterizing the safety and/or efficacy of study drug in relation to the pharmacogenic (genetic) profile of the patient. Periodically during the study, patients will be assessed for the presence of psychiatric symptoms and severity of symptoms. The safety and tolerability of paliperidone will be evaluated by monitoring adverse events (side effects) and relevant changes in laboratory values, electrocardiogram (ECG), vital signs measurements, physical examinations, and extrapyramidal symptoms (ie, symptoms that can be associated with taking antipsychotic drugs) scores reported from the time of screening to the end of the study (Day 372 or at the time of the patient's early termination from the study). The concentration of paliperidone in plasma (colorless portion of blood) from blood samples collected from Day 1 through to the end of the study will also be determined. Since only limited information exists regarding the repeated administration of doses of paliperidone palmitate, an internal review board will meet 2 times during the study to review safety data collected. The first review of safety data will be performed after approximately 30 patients complete 99 days of treatment and the second review of safety data will be made after approximately 75 patients complete 176 days of treatment. After each review of safety data, the safety review board will make a recommendation to continue the study, modify the protocol, or to terminate the study. Patients will receive 1 injection in the deltoid muscle of Treatment (Tx) A (study drug 150mg eq) on Day 1. Patients will then receive 1 injection in the deltoid muscle of Tx A on Day 8 followed by 1 injection every 4 weeks in the deltoid or gluteal muscle OR patients will be assigned to Txt B and receive 1 injection in the deltoid or gluteal muscle of study drug 100mg eq at next visit followed by 1 injection every 4 weeks of study drug 50 to 150mg eq in the deltoid or gluteal muscle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
  • Croatia
      • Zagreb, Croatia
  • Korea, Republic of
      • Gwangju, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Poland
      • Leszno N/A, Poland
      • Lubliniec, Poland
      • Poznan, Poland
      • Torun N/A, Poland
  • Slovakia
      • Bratislava, Slovakia
      • Michalovce, Slovakia
      • Rimavska Sobota, Slovakia
  • Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Madrid, Spain
  • Taiwan
      • Hua Lian, Taiwan
      • Kaohsiung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Tao-Yuan, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand
  • United States
    • California
      • Cerritos, California, United States
      • National City, California, United States
      • San Diego, California, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening
  • Have a body mass index (BMI) of >=17.0 kg/m2 at screening
  • Have a Positive and Negative Syndrome Scale (PANSS) total score of <=70

Exclusion Criteria:

  • Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
  • Have a PANSS total score of >70 at screening
  • Have a PANSS score of >16 points on the sum of the following 4 items at screening and baseline: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content
  • Have scores greater than 5 on any of the individual items of the PANSS at screening or baseline
  • Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 001
Paliperidone palmitate Treatment A All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.
Drug: Paliperidone palmitate Treatment A
All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.
Experimental: 002
Paliperidone palmitate Treatment B Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq patients who do not wish to have multiple blood samples collected will also be assigned to Treatment B
Drug: Paliperidone palmitate Treatment B
Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number of patients experiencing treatment emergent adverse events
Time Frame: Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study)
Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study)
Concentration of paliperidone in plasma from blood samples obtained from patients
Time Frame: Day 1 to Day 372
Day 1 to Day 372

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in Sleep Visual Analog Scale (Sleep VAS) scores as an indicator of quality of sleep and daytime drowsiness
Time Frame: Day 1 to Day 372.
Day 1 to Day 372.
Changes in Positive and Negative Syndrome Scale (PANSS) scores
Time Frame: Day 1 to Day 372.
Day 1 to Day 372.
Change in Clinical Global Impression Severity of Illness (CGI-S) Scores as an indicator of overall clinical condition
Time Frame: Day 1 to Day 372.
Day 1 to Day 372.
Changes in Personal and Social Performance Scale (PSP) Scores (measures personal and social performance in patients with acute symptoms of schizophrenia. Higher PSP scores indicate better personal and social functioning)
Time Frame: Day 1 to Day 372.
Day 1 to Day 372.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR013300
  • R092670PSY1008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings