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A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
NCT01130493 · View on ClinicalTrials.gov ↗
Study Summary
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
Conditions Studied
Interventions
- DRUG IPX066
- DRUG CLE
Study Locations (20)
Other
- Hôpital Gabriel Montpied-Service de Neurologie A- — Clermont-Ferrand
- Service de neurologie-Hôpital de la Timone- — Marseille
- Praxis für Neurologie, Psychiatrie und Psychotherapie Achim — Achim
- Praxis Dres. Bitter/Schumann — Bochum
- Klinikum rechts der Isar der Technischen Universität München — München
- Klinik für Neurologie, Stadtroda — Stadtroda
- RKU, Neurologische Klinik der Universität Ulm — Ulm
- Casa di Cura Villa Margherita — Arcugnano
Florida
- UM Movement Disorders Center — Miami
- Charlotte Neurological Services — Port Charlotte
- USF Parkinson's and Movement Disorders Center — Tampa
California
- Margolin Brain Institute — Fresno
- The Parkinson's Institute in Sunnyvale — Sunnyvale
New York
- Parkinson's Disease and Movement Disorders Center of Long Island — Commack
- Kingston Neurological Associates — Kingston
Michigan
- Quest Research Institute — Bingham Farms
Nevada
- University Health Systems — Las Vegas
Ohio
- University Neurology, Inc — Cincinnati
Virginia
- Sentara Neurological Associates — Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01130493
The ClinicalTrials.gov registry entry for NCT01130493 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which IPX066 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01130493 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01130493 about?
NCT01130493 is a clinical study titled "A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066". This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
What is the current status of trial NCT01130493?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2010-05. Estimated completion is 2012-01.
What conditions does trial NCT01130493 study?
This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01130493?
The interventions under investigation include: IPX066 (DRUG), CLE (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01130493?
This trial is sponsored by Impax Laboratories, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01130493 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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