A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia

NCT01258920 | Completed Phase 3

• 2 other identifiers: CR017077PALM-JPN-5
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 29

Brief Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this study are to: explore the efficacy on symptoms of schizophrenia and the maintenance of treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse pharmacokinetic sampling.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone palmitate; Intramascular Injection

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  49 Weeks

Secondary Outcomes (3)

• The change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

  Baseline, Week 49

• The change from baseline in Clinical Global Impression - Severity (CGI-S) score

  Baseline, Week 49

• Pharmacokinetic evaluations (graphically display to explore dose proportionality and achievement of steady state)

  49 Weeks (Baseline, Week 1, 5, 9, 13, 21, 25, 37, 45, 47 and 49)

Study Arms (1)

Paliperidone palmitate

EXPERIMENTAL

Paliperidone palmitate Paliperidone palmitate will be administered im as an initial loading dose of 150 mg eq. on Day 1 and 100 mg eq. 1 week later in the deltoid muscle and will be administered in a flexible dose range of 25 to 150 mg eq. at 4-week intervals from Week 5 for a total of 11 injections.

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate DRUG

Paliperidone palmitate will be administered im as an initial loading dose of 150 mg eq. on Day 1 and 100 mg eq. 1 week later in the deltoid muscle, and will be administered in a flexible dose range of 25 to 150 mg eq. at 4-week intervals from Week 5 for a total of 11 injections.

Paliperidone palmitate

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Met diagnostic criteria for schizophrenia according to DSM-IV-TR (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
• A PANSS total score of 60 to 120 at screening and baseline (Day 1)
• Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1). (Even if the patient's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the patient will be able to meet this criterion if the patient takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the patient)
• Women of childbearing potential must have a negative ß-human chorionic gonadotropin (ß-hCG) pregnancy test at the screening urine pregnancy test
• Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Primary active DSM-IV-TR Axis I diagnosis other than schizophrenia
• Relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
• History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
• Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (29)

Unknown Facility

Asahi, Japan

Location

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Fujioka, Japan

Location

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Fujisawa, Japan

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Hachiōji, Japan

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Higashimurayama, Japan

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Hiroshima, Japan

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Iizuka, Japan

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Kanuma, Japan

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Kashihara, Japan

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Kashiwara, Japan

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Kochi, Japan

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Kure, Japan

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Maebashi, Japan

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Moriguchi, Japan

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Nagasaki, Japan

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Nirasaki, Japan

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Ohta, Japan

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Sapporo, Japan

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Shimonoseki, Japan

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Shinjyuku, Japan

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Takatsuki, Japan

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Tama, Japan

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Tokushima, Japan

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Tokyo, Japan

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Ube, Japan

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Ueda, Japan

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Uji, Japan

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Yokohama, Japan

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Yokosuka, Japan

Location

Related Links

• A Long-Term, Open-Label Study of Flexibly Dosed Paliperidone Palmitate Long-Acting Intramuscular Injection in Japanese Subjects With Schizophrenia

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: December 13, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

JP (29)