A Study of Paliperidone Palmitate 6-Month Formulation

Schizophrenia Clinical Trial

Official title:

Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072575
• Other study ID #: CR108605
• Secondary ID: R092670PSY301620
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2019
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 3, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)
• Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study
• A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b) Use contraception consistent with local regulations. A man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) His female partner(s) will use highly effective method pf contraception
• Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant)
• In the opinion of the investigator, the patient would be able to participate for the duration of this study

Exclusion Criteria:

• Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
• If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• PP6M injection Dose 1
Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.
• PP6M injection Dose 2
Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.

Locations

Country	Name	City	State
Argentina	Fundación para el Estudio y Tratamiento de las Enfermedades Mentales	Ciudad Autónoma De Buenos Aires
Argentina	CEN-Consultorios Especializados en Neurociencias	Cordoba
Argentina	Sanatorio Prof. Leon S. Morra	Cordoba
Argentina	Clinica Privada de Salud Mental Santa Teresa de Ávila	La Plata
Argentina	INSA Instituto de Neurociencias San Agustín	La Plata
Argentina	C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)	Rosario
Hong Kong	Queen Mary Hospital	Hong Kong
Italy	Dipartimento di Salute Mentale	Lecce
Italy	Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria	Napoli
Italy	Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea	Roma
Poland	Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk	Bialystok
Poland	Zespol Opieki Zdrowotnej w Chelmnie	Chelmno
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk
Poland	Specjalistyczna Praktyka Lekarska Piotr Zalitacz	Gorlice
Poland	Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS	Leszno
Poland	Centrum Medyczne Luxmed Sp z o o	Lublin
Poland	Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim	Pruszcz Gdanski
Russian Federation	Sverdlovsk Regional Clinical Psychiatric Hospital	Ekaterinburg
Russian Federation	Nizny Novgorod clinical psychiatric hospital 1	Nizny Novgorod
Russian Federation	Saratov Regional Psychiatric hospital named after St. Sofia	Saratov
Russian Federation	SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky	Saratov
Russian Federation	Research Institute of Mental Health	Tomsk
Ukraine	MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association	Glevakha
Ukraine	Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'	Kharkiv
Ukraine	CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council	Kherson
Ukraine	CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'	Lviv
Ukraine	Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'	Lviv
Ukraine	CNCE Odesa regional psychiatric hospital #2 Odesa regional council	Oleksandrivka
Ukraine	CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'	Smila
Ukraine	CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Argentina,  Hong Kong,  Italy,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Relapse	Number of participants with relapse were reported. Relapse is defined as one or more of the following: a) Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms); b) Emergency Department/Room/Ward visit due to a worsening of the participant's symptoms of schizophrenia, but a psychiatric hospitalization does not occur; c) The participant inflicts deliberate self-injury or exhibits violent behaviour resulting in suicide, clinically significant injury to him/herself or another person, or significant property damage; d) The participant has suicidal or homicidal ideation and aggressive behaviour that is clinically significant (in frequency and severity) in the investigator's judgment.	Up to Day 730
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events if they started after administration of the first dose and until 183 days after the last dose of study medication.	Up to Day 730
Secondary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score	Change from baseline in CGI-S scale score was reported. CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill participants. A higher score implies a more severe condition.	Baseline up to Day 730
Secondary	Change From Baseline in Personal and Social Performance (PSP) Scale Score	Change from baseline in PSP scale score was reported. The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 had mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance.	Baseline up to Day 730
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from baseline in PANSS total score were reported. The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale of 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).	Baseline up to Day 730