Status:
COMPLETED
A Study of Paliperidone Palmitate 6-Month Formulation
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04072575
Start Date
September 19 2019
End Date
May 3 2022
Last Update
April 29 2025
Active Locations (30)
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1
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, Argentina, C1133AAH
2
CEN Consultorios Especializados en Neurociencias
Córdoba, Argentina, X5004FJF
3
Sanatorio Prof. Leon S. Morra
Córdoba, Argentina, X5009BIN
4
INSA Instituto de Neurociencias San Agustín
La Plata, Argentina, 1900