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Clinical Trials in the USA / NCT07219927
Recruiting Observational

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

NCT07219927 · tracked via the Priya Life Science USA tracker
Sponsor
Supernus Pharmaceuticals, Inc
Phase
Observational
Started
2025-03-31
Last updated
2025-10-22

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Observational study

Observational study: Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: 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).

Primary outcome measure(s)

  • Titration Duration and Time to Optimized Dose — Approximately 52-60 weeks
    The time from the date of ONAPGO™ initiation to the date of Dose Optimization Confirmation, as documented by the HCP/Investigator Unit of Measure: days
  • Concomitant Parkinson's Disease (PD) Medication Adjustments — Approximately 52-60 week
    Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. "Percentage of participants"
  • The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event — Approximately 52-60 weeks
    Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant

Trial sites (5)

FacilityCityRegionStatus
Parkinson's Disease and Movement Disorders Center - Orange County (South) Aliso Viejo California Recruiting
Parkinson's Disease and Movement Disorders Center - Orange County (North) Irvine California Recruiting
Parkinson's Research Centers of America - Palo Alto Palo Alto California Recruiting
Parkinson's Disease & Movement Disorders Center of Boca Raton Boca Raton Florida Recruiting
Parkinson's Disease and Movement Disorders Center - Long Island Commack New York Recruiting

More Supernus Pharmaceuticals, Inc. trials in the USA

Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy Recruiting
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures Recruiting
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures Enrolling by invitation
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD Recruiting
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) Active, not recruiting

Other trials for the same condition

First-in-Human Single and Multiple Dose of HL-400 Recruiting
Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies Recruiting
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations Recruiting
Parkinson's Disease Progression Study Active, not recruiting
Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219927 on ClinicalTrials.gov ↗ ← All trials in the USA