- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150448
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
212
Phase
- 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
-
-
-
Aalst, Belgium
-
-
-
-
-
Zagreb, Croatia
-
-
-
-
-
Gwangju, Korea, Republic of
-
Incheon, Korea, Republic of
-
Seoul, Korea, Republic of
-
-
-
-
-
Kuala Lumpur, Malaysia
-
-
-
-
-
Leszno N/A, Poland
-
Lubliniec, Poland
-
Poznan, Poland
-
Torun N/A, Poland
-
-
-
-
-
Bratislava, Slovakia
-
Michalovce, Slovakia
-
Rimavska Sobota, Slovakia
-
-
-
-
-
Badalona, Spain
-
Barcelona, Spain
-
Madrid, Spain
-
-
-
-
-
Hua Lian, Taiwan
-
Kaohsiung, Taiwan
-
Tainan, Taiwan
-
Taipei, Taiwan
-
Tao-Yuan, Taiwan
-
-
-
-
-
Bangkok, Thailand
-
Chiang Mai, Thailand
-
-
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
|
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
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
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.
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.
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
September 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 17, 2010
First Submitted That Met QC Criteria
June 24, 2010
First Posted (Estimate)
June 25, 2010
Study Record Updates
Last Update Posted (Estimate)
May 28, 2014
Last Update Submitted That Met QC Criteria
May 26, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID 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.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Rakitzi, StavroulaActive, not recruiting
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
Clinical Trials on Paliperidone palmitate Treatment A
-
Janssen Research & Development, LLCCompletedSchizophreniaUnited States, Belgium, Taiwan, Spain, Israel, Malaysia, South Africa, Korea, Republic of, Slovakia, Croatia, Bulgaria
-
Janssen-Cilag International NVActive, not recruiting
-
Janssen Research & Development, LLCCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophreniaUnited States, Ukraine, Taiwan, Malaysia, Romania, Russian Federation, Serbia, Korea, Republic of
-
Vir Biotechnology, Inc.GlaxoSmithKlineTerminatedCovid19United States, France, Ukraine
-
Seoul National University HospitalCompleted
-
Epirium Bio Inc.CompletedBecker Muscular DystrophyUnited States
-
Luye Pharma Group Ltd.CompletedMental Disorders | Psychotic Disorders | Mood Disorders | Schizophrenia | Schizophrenia Spectrum and Other Psychotic Disorders | Molecular Mechanisms of Pharmacological Action | Tranquilizing Agents | Physiological Effects of Drugs | Psychotropic Drugs | Antipsychotic Agents | Neurotransmitter Agents | Central...United States
-
Calo Psychiatric CenterCompleted
-
H. Lundbeck A/SOtsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaUnited States