- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01529515
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
2 maj 2016 uppdaterad av: Janssen Research & Development, LLC
A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study.
The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase).
Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29.
Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo.
The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.
Studietyp
Interventionell
Inskrivning (Faktisk)
509
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Barranquilla, Colombia
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Bogota, Colombia
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Medellin, Colombia
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Pereira, Colombia
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Arkansas
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Little Rock, Arkansas, Förenta staterna
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California
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San Fran Cisco, California, Förenta staterna
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District of Columbia
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Washington, District of Columbia, Förenta staterna
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Florida
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Lauderhill, Florida, Förenta staterna
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Illinois
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Chicago, Illinois, Förenta staterna
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Hoffman Estates, Illinois, Förenta staterna
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Kansas
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Topeka, Kansas, Förenta staterna
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Maryland
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Baltimore, Maryland, Förenta staterna
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Mississippi
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Flowood, Mississippi, Förenta staterna
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New Jersey
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Marlton, New Jersey, Förenta staterna
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New York
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Cedarhurst, New York, Förenta staterna
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna
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Texas
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Austin, Texas, Förenta staterna
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Dallas, Texas, Förenta staterna
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Utah
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Salt Lake City, Utah, Förenta staterna
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Diyarbakir, Kalkon
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Sakarya, Kalkon
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Deajun, Korea, Republiken av
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Gyeongsangnam-Do, Korea, Republiken av
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Incheon, Korea, Republiken av
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Seongnam, Korea, Republiken av
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Tanjong Rambutan, Malaysia
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Guadajalara, Mexiko
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Mexico City, Mexiko
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Monterrey, Mexiko
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San Luis Potosi, Mexiko
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Zapopan, Mexiko
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Arad, Rumänien
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Craiova, Rumänien
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Iasi, Rumänien
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Sibiu, Rumänien
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Tg Mures, Rumänien
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Donetsk, Ukraina
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Evpatoriya, Ukraina
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Glevakha, Ukraina
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Ivano-Frankivsk, Ukraina
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Kerch, Ukraina
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Kharkiv, Ukraina
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Kharkov, Ukraina
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Kherson, Ukraina
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Kiev, Ukraina
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Lviv, Ukraina
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Lvov, Ukraina
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Odesa, Ukraina
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Odessa, Ukraina
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Poltava, Ukraina
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Smela, Ukraina
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Ternopil, Ukraina
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Uzhgorod, Ukraina
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Vinnitsa, Ukraina
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients with schizophrenia for more than 1 year
- A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
- Signed informed consent
- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- Men must agree to use a double-barrier method of birth control
- Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- A diagnosis of substance dependence within 6 months before screening
- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo
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Form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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Experimentell: Paliperidone palmitate 3-month (PP3M)
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Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to Relapse During the Double-Blind Phase
Tidsram: Approximately Week 60
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Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event.
Median time to relapse was estimated by the Kaplan-Meier method.
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Approximately Week 60
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Tidsram: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PANSS 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 is rated 1 (absent) to 7 (extreme).
The total score ranging from 30 to 210.
Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Tidsram: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Tidsram: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior.
The results of the assessment were converted to a numerical score which ranges from 1 to 100.
A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
- Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
- Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.
- Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.
- Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.
- Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2012
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
6 februari 2012
Först inskickad som uppfyllde QC-kriterierna
8 februari 2012
Första postat (Uppskatta)
9 februari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 maj 2016
Senast verifierad
1 maj 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR100717
- R092670PSY3012 (Annan identifierare: Janssen Research & Development, LLC)
- 2011-004676-11 (EudraCT-nummer)
- U1111-1135-1969 (Annan identifierare: Universal Trial Number)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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