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NCT02611713 · ClinicalTrials.gov registry record
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
A clinical trial, sponsored by AbbVie.
- Completed
- Registry status
- 213
- Enrollment target
NCT02611713: Completed study, sponsored by AbbVie.
NCT02611713 is a clinical trial that has completed, run by AbbVie. The registered enrollment target is 213 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611713 has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- 213 participants
- Enrollment target
Study Summary
This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.
Primary Outcome
Assess the effectiveness of Duodopa/Duopa treatment on OFF time measured by the change (from baseline to 36 months) in the number of hours spent in OFF time as reported by the participant for the day prior to the clinical visit.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2016-01-04 |
| Est. Completion | 2020-12-24 |
What the finished NCT02611713 record still lists
NCT02611713 is an observational study that tracks outcomes without assigning an intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02611713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02611713 about?
NCT02611713 is a clinical study titled "Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease". This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginnin...
What is the current status of trial NCT02611713?
This trial is currently completed. The enrollment target is 213 participants. The study started on 2016-01-04. Estimated completion is 2020-12-24.
Who is sponsoring clinical trial NCT02611713?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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