7/9/2020
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`Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia - Full Text View - ClinicalTrials.gov
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`Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
`
`The safety and scientific validity of this study is the responsibility of the study sponsor and
`investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
`Read our disclaimer for details.
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`
`ClinicalTrials.gov Identifier: NCT00589914
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`Recruitment Status  : Completed
`First Posted  : January 10, 2008
`Results First Posted  : October 4, 2011
`Last Update Posted  : June 24, 2014
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`Sponsor:
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Information provided by (Responsible Party):
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Study Details
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`Study Description
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`Brief Summary:
`The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.
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`Condition or disease 
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`Intervention/treatment 
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`Schizophrenia
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`Drug: RISPERDAL CONSTA
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`Drug: Paliperidone palmitate
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`Phase 
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`Phase 3
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`Detailed Description:
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`Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia - Full Text View - ClinicalTrials.gov
`This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the
`treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting
`Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For
`those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER)
`tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another
`antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be
`administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL
`CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone
`palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day
`8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6
`(Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take
`risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9.
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`Study Design
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`Interventional (Clinical Trial)
`Study Type  :
`Actual Enrollment  : 1221 participants
`Allocation: Randomized
`Intervention Model: Parallel Assignment
`Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`Official Title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of
`Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular
`Injection in Subjects With Schizophrenia
`Study Start Date  : March 2007
`Actual Primary Completion Date  : June 2009
`Actual Study Completion Date  : June 2009
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`Resource links provided by the National Library of Medicine
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`Genetics Home Reference related topics: Schizophrenia
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`MedlinePlus related topics: Schizophrenia
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`Drug Information available for: Risperidone Paliperidone Paliperidone Palmitate
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`U.S. FDA Resources
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`Arms and Interventions
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`Arm 
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`Intervention/treatment 
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`Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia - Full Text View - ClinicalTrials.gov
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`Arm 
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`Intervention/treatment 
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`Active Comparator: RISPERDAL CONSTA
`RISPERDAL CONSTA 25-50 mg eq every 2 weeks
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`Experimental: R092670
`Paliperidone Palmitate 50-150 mg eq every 4 wks
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`Drug: RISPERDAL CONSTA
`RISPERDAL CONSTA: Type=exact number, unit=mg,
`number=25, 37.5, or 50, form=suspension for injection,
`route=Intramuscular use. One i.m. injection of
`RISPERDAL CONSTA 25-50 mg eq every 2 weeks at
`V4, V6, V7, V8, V9, and V10. PALIPERIDONE
`PALMITATE PLACEBO: Form=suspension for injection,
`route=Intramuscular use. One i.m. injection every 2
`weeks at Baseline and at V4, V7, and V9.
`RISPERIDONE: Type=up to, unit=mg, number=1 to 6,
`form=Tablet, route=Oral Use. One tablet for the first 4
`weeks (28 days) of the DB treatment period.
`
`Drug: Paliperidone palmitate
`PALIPERIDONE PALMITATE: Type=exact number,
`unit=mg, number=50, 100, or 150, form=suspension for
`injection, route=Intramuscular use. One i.m. injection of
`Paliperidone palmitate 50-150 mg eq every 4 wks at
`Baseline, V4, V7, and V9. RISPERDAL CONSTA
`PLACEBO: Form=suspension for injection,
`route=Intramuscular use. One i.m. injection every 4
`weeks at Baseline, V4, V7, and V9.
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`Outcome Measures
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`Primary Outcome Measures  :
`1. Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia [ Time Frame: Baseline
`to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks) ]
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`The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale
`provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items),
`the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of
`1 (absent) to 7 (extreme).
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`Secondary Outcome Measures  :
`1. The Change From Baseline for the CGI-S Score [ Time Frame: Baseline to the last postrandomization assessment
`in the double-blind treatment period (approximately 13 weeks)] ]
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`The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging
`from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given
`time. A qualified rater administered the CGI-S.
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`2. The Change From Baseline in the PSP Score [ Time Frame: Baseline to the last postrandomization assessment in
`the double-blind treatment period (approximately 13 weeks) ]
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`The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4
`domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and
`aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and
`100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction,
`and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.
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`Eligibility Criteria
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`Information from the National Library of Medicine
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`Choosing to participate in a study is an important personal decision. Talk with your doctor and
`family members or friends about deciding to join a study. To learn more about this study, you or
`your doctor may contact the study research staff using the contacts provided below. For general
`information, Learn About Clinical Studies.
`
`Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study: All
`Accepts Healthy Volunteers: No
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`Criteria
`Inclusion Criteria:
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`Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth
`Edition (DSM-IV) criteria as specified by the protocol 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 total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass index (BMI) at the
`screening visit BMI at least 17 kg/m2
`Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be
`practicing an effective method of birth control before study entry and throughout the study as specified by the protocol.
`Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy
`test result at screening.
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`Exclusion Criteria:
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`Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; A primary, active DSM-IV
`diagnosis on Axis I other than schizophrenia
`A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not
`exclusionary)
`History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic
`medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
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`Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including
`seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other
`systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing
`gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients
`requiring oral tolerability only)
`Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening
`allergic reaction to any drug; Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20%
`Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
`Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months
`before screening; History of any active malignancy within the previous 5 years, with the exception of basal cell
`carcinomas
`Women who are pregnant or breast-feeding or are planning to become pregnant uring the study
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`Contacts and Locations
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`Information from the National Library of Medicine
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`To learn more about this study, you or your doctor may contact the study research staff using
`the contact information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589914
`
`Locations
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` Show 87 study locations
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`Sponsors and Collaborators
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Investigators
`Study Director:
`
`Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
`
`Johnson & Johnson
`
`More Information
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`Additional Information:
`
`Go to
`
`A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible
`Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia
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`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting
`injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi:
`10.1517/14656566.2014.909409.
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`Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia - Full Text View - ClinicalTrials.gov
`Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting
`injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin
`Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.
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`Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in
`markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr
`Relat Psychoses. 2014 Jul;8(2):101-9, 109A. doi: 10.3371/CSRP.FUBO.022213.
`
`Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of
`paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol
`Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.
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`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT00589914 History of Changes
`Other Study ID Numbers:
`CR012289
`R092670PSY3006 ( Other Identifier: Unique Protocol Number )
`January 10, 2008 Key Record Dates
`October 4, 2011
`June 24, 2014
`June 2014
`
`First Posted:
`Results First Posted:
`Last Update Posted:
`Last Verified:
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`Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
`Schizophrenia
`long-acting injectable antipsychotic medication
`
`Additional relevant MeSH terms:
`Schizophrenia
`Schizophrenia Spectrum and Other Psychotic Disorders
`Mental Disorders
`Paliperidone Palmitate
`Risperidone
`Antipsychotic Agents
`Tranquilizing Agents
`Central Nervous System Depressants
`Physiological Effects of Drugs
`
`Psychotropic Drugs
`Serotonin 5-HT2 Receptor Antagonists
`Serotonin Antagonists
`Serotonin Agents
`Neurotransmitter Agents
`Molecular Mechanisms of Pharmacological Action
`Dopamine D2 Receptor Antagonists
`Dopamine Antagonists
`Dopamine Agents
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