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NCT02271503 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

A Phase 2 study, sponsored by Impax Laboratories.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target

NCT02271503: Completed Phase 2 study, sponsored by Impax Laboratories.

NCT02271503 is a Phase 2 study that has completed, run by Impax Laboratories. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02271503, a Phase 2 study, has completed, sponsored by Impax Laboratories.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target

Study Summary

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

Interventions

  • DRUG CD-LD IR
  • DRUG IPX203 180 mg
  • DRUG IPX203 270 mg
  • DRUG Rytary 195 mg
  • DRUG Rytary 145 mg

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2015-11
Est. Completion 2016-08
Phase Phase 2
Impax Laboratories

19 total trials

What the finished NCT02271503 record still lists

NCT02271503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 5 interventions - of which CD-LD IR is the first listed.

NCT02271503 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02271503 about?

NCT02271503 is a clinical study titled "A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease". This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharma...

What is the current status of trial NCT02271503?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2015-11. Estimated completion is 2016-08.

What interventions are being tested in trial NCT02271503?

The interventions under investigation include: CD-LD IR (DRUG), IPX203 180 mg (DRUG), IPX203 270 mg (DRUG), Rytary 195 mg (DRUG), Rytary 145 mg (DRUG).

Who is sponsoring clinical trial NCT02271503?

This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02271503's enrollment target sits among peer trials

26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02271503, the US trial registry maintained by the National Library of Medicine. NCT02271503 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.