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NCT03877510 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 419
- Enrollment target
NCT03877510: Completed Phase 3 study, sponsored by Impax Laboratories.
NCT03877510 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 419 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03877510, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 419 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as tre
Interventions
- DRUG IPX203
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2019-04-03 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 3 |
What the finished NCT03877510 record still lists
NCT03877510 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 1 intervention - of which IPX203 is the first listed.
NCT03877510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03877510 about?
NCT03877510 is a clinical study titled "Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations". The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
What is the current status of trial NCT03877510?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2019-04-03. Estimated completion is 2022-03-21.
What interventions are being tested in trial NCT03877510?
The interventions under investigation include: IPX203 (DRUG).
Who is sponsoring clinical trial NCT03877510?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03877510's enrollment target sits among peer trials
419 899th of 2000 higher than 1,101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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