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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 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 630 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03670953
The ClinicalTrials.gov registry entry for NCT03670953 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which IR CD-LD is the first listed.
NCT03670953 reports 0 study locations.
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.
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