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NCT03670953 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
NCT03670953: Completed Phase 3 study, sponsored by Impax Laboratories.
NCT03670953 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 630 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03670953, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
Primary Outcome
"Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB).
Interventions
- DRUG IR CD-LD
- DRUG IPX203 ER CD-LD
- OTHER Placebo Matching IPX203
- OTHER Placebo Matching IR CD-LD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 3 |
What the finished NCT03670953 record still lists
NCT03670953 is an interventional study that assigns participants to a tested intervention. The registered 630 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 (18% lower).
The record links to 0 conditions, and to 4 interventions - of which IR CD-LD is the first listed.
NCT03670953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03670953 about?
NCT03670953 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations". To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
What is the current status of trial NCT03670953?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 630 participants. The study started on 2018-11-06. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT03670953?
The interventions under investigation include: IR CD-LD (DRUG), IPX203 ER CD-LD (DRUG), Placebo Matching IPX203 (OTHER), Placebo Matching IR CD-LD (OTHER).
Who is sponsoring clinical trial NCT03670953?
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 NCT03670953's enrollment target sits among peer trials
630 581st of 2000 higher than 1,417 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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