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

CompletadoFase 3ClinicalTrials.gov

ID: NCT04072575Tipo: INTERVENTIONALInicio: 19 de sept de 2019Fin estimado: 3 de may de 2022

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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.

drug

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.

Ubicaciones

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

Sanatorio Prof. Leon S. Morra

Córdoba, Argentina

INSA Instituto de Neurociencias San Agustín

La Plata, Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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