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NCT01411137 · ClinicalTrials.gov registry record · Phase 3
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT01411137 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 43 participants.
The verdict
NCT01411137, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
The study had three distinct parts and is described as follows: Part 1: * To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD * To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects. Part 2: • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study. Part 3: • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.
Interventions
- DRUG IPX066
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01411137
The ClinicalTrials.gov registry entry for NCT01411137 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 43 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 1 intervention - of which IPX066 is the first listed.
NCT01411137 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01411137 about?
NCT01411137 is a clinical study titled "Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study". The study had three distinct parts and is described as follows: Part 1: * To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD * To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an explorato...
What is the current status of trial NCT01411137?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2011-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01411137?
The interventions under investigation include: IPX066 (DRUG).
Who is sponsoring clinical trial NCT01411137?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
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