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Paliperidone OROS

Phase 3

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment349

FDA Designations

No designations recorded

Clinical trial landscape

Paliperidone OROS · 3 trials · 1 indication

Phase 3 2Phase 1 1
NCT0075242724-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With SchizophreniaSchizophrenia
COMPLETED86 Analytics
NCT00210769A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With SchizophreniaSchizophrenia
COMPLETED203 Analytics
PHASE3COMPLETED
24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
Schizophrenia
NCT0075242786
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PHASE3COMPLETED
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
Schizophrenia
NCT00210769203
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Study Endpoints

Primary Endpoints

Long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.
Safety and tolerability of extended-release (ER) OROS paliperidone in healthy Japanese and Caucasian adults. Paliperidone plasma concentrations, time profiles and PK parameters after single and multiple dosing for Japanese and Caucasian patients.

Secondary Endpoints

Assessment of long-term efficacy of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, .
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).
Pharmacogenomics: Relationships between composite genetic description or predicted observable traits and the pharmacokinetic parameters of paliperidone and its enantiomers were explored graphically.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Paliperidone ER OROS®DRUG -
paliperidone ER OrosDRUG -
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the su...

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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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Frequently asked questions about Paliperidone OROS

What is Paliperidone OROS used for in schizophrenia?

Paliperidone OROS is an investigational small molecule being studied for the treatment of schizophrenia. It is an extended-release oral formulation of paliperidone. The drug is being developed by Johnson & Johnson and is currently in Phase 3 clinical trials.

What does Paliperidone OROS target?

Paliperidone OROS is an extended-release formulation of paliperidone, an atypical antipsychotic. It is being studied for schizophrenia. The drug is in Phase 3 development by Johnson & Johnson.

Who makes Paliperidone OROS?

Paliperidone OROS is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 3 clinical trials for the treatment of schizophrenia.

What phase is Paliperidone OROS in?

Paliperidone OROS is in Phase 3 clinical development. It is an investigational drug, not yet approved, being studied for schizophrenia. The development program includes completed Phase 3 trials, and the drug is not currently in active trials.

What clinical trials is Paliperidone OROS in?

Paliperidone OROS has been studied in clinical trials including NCT00210769, a long-term safety and effectiveness study in schizophrenia, and NCT00752427, a 24-week open-label extension in geriatric subjects. A Phase 1 pharmacokinetic study, NCT00758030, was also completed.

Is Paliperidone OROS the same as paliperidone?

Paliperidone OROS is an extended-release oral formulation of paliperidone. It is being developed by Johnson & Johnson for schizophrenia. The OROS technology provides controlled release of the drug, and it is currently in Phase 3 clinical trials.