Phase 2 N=56 Randomized Treatment

A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01606254 ↗

Enrolled (actual)

Serious AEs

10.7%

Results posted

Apr 2013

Primary outcome: Primary: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 — 5.85; 7.28; 28.4; 12.1 ng/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Paliperidone palmitate (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Janssen Pharmaceutical K.K.
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8	5.85; 7.28; 28.4; 12.1	—
PRIMARY Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36	6.77; 14.5; 23.4; 19.5	—
PRIMARY Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64	6.86; 15.1; 22.9; 14.3	—
PRIMARY Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92	8.41; 15.2; 25.4; 13.5	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) of Paliperidone	13.7; 33.5; 43.1; 21.6	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone	10.99; 7.89; 7.50; 3.82	—
PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	7081; 15898; 21853; 11109	—
PRIMARY Plasma Paliperidone Concentration at Steady State (Css av)	10.7; 23.9; 32.8; 16.7	—
PRIMARY Paliperidone Plasma Decay Half-Life (t1/2)	68.1; 58.5; 95.5; 104.4	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8	6; 9; 6; 6; 8; 5	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22	7; 7; 6; 6; 7; 6	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50	11; 7; 8; 6; 3; 5	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78	9; 8; 8; 6; 4; 4	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92	7; 7; 7; 5; 6; 5	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120	9; 6; 6; 6; 4; 5	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162	9; 7; 6; 7; 3; 4	—
PRIMARY Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218	9; 7; 6; 6; 3; 4	—
SECONDARY Positive and Negative Syndrome Scale (PANSS) Total Score	61.9; 60.7; 60.4; 63.9; 60.0; 59.6	—
SECONDARY Number of Participants With Clinical Global Impression Severity (CGI-S) Score	3; 4; 3; 1; 8; 6	—

Summary

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Eligibility Criteria

Inclusion Criteria

Participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
Participants may be inpatients or outpatients
Participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) at screening
Participants who have taken risperidone by the start of investigational treatment and the record can be confirmed Exclusion Criteria
Participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
Participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
Participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
Participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
Participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition

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Data sourced from ClinicalTrials.gov (NCT01606254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.