Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:

Официальное название

Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease

Обзор

Real-World Participants Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease

Подробное описание

This observational study includes an Enrollment Day (participants enrolled any time between their prescription for the infusion and ONAPGO initiation); a Baseline Period (prior to ONAPGO initiation which includes in-home education on the use of ONAPGO by the Clinical Nurse Navigator \[CNN\] according to standard practice for patients with PD-prescribed ONAPGO); Dose Initiation, Titration, and Optimization per Prescription Periods; a Maintenance Period; Maintenance CNN standard of care visits; and an End-of-Study (EOS)/Discontinuation Visit.

Вмешательства

• Другое Observational study
  Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Первичные конечные точки

• Titration Duration and Time to Optimized Dose [Срок оценки: Approximately 52-60 weeks]
• Concomitant Parkinson's Disease (PD) Medication Adjustments [Срок оценки: Approximately 52-60 week]
• The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event [Срок оценки: Approximately 52-60 weeks]

Вторичные конечные точки (5)

• Perception of Patient Global Health Improvement [Срок оценки: Approximately 52-60 weeks]
• Caregiver Burden [Срок оценки: Approximately 52-60 weeks]
• HCP/Investigator burden for ONAPGO providers [Срок оценки: Approximately 52-60 weeks]
• Evaluation of ONAPGO usage during the maintenance period [Срок оценки: Approximately 52-60 weeks]
• Safety by monitoring adverse events (AEs) [Срок оценки: Approximately 52-60 weeks]

Критерии участия

Критерии включения

Participant has received a prescription for ONAPGO™ according to the standard of care.

Participant has opted into receiving support services from the Clinical Nurse Navigator (CNN), a registered nurse specially trained to work with persons with Parkinson's disease, as noted on the Prescription Enrollment Form.

The HCP/Investigator determines the participant is an appropriate study participant.

Participant is able and willing to provide informed consent (or informed assent form \[IAF\], as applicable) and signs the consent form on the Enrollment Day.

Критерии исключения

Did not receive a prescription for ONAPGO™.

Prescribed ONAPGO™, but the HCP/Investigator determines the participant should not participate in this observational study.

Concomitant use of ONAPGO™ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron.

Known hypersensitivity to apomorphine or to excipients of ONAPGO™, including sulfite (e.g., sodium metabisulfite).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Parkinson's Disease and Movement Disorders Center - Orange County (South) — Aliso Viejo
• Parkinson's Disease and Movement Disorders Center - Orange County (North) — Irvine
• Parkinson's Research Centers of America - Palo Alto — Palo Alto
• Parkinson's Disease & Movement Disorders Center of Boca Raton — Boca Raton
• Parkinson's Disease and Movement Disorders Center - Long Island — Commack

Идентификаторы

NCT: NCT07219927 · 830P401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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