Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
NCT01096186 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
Conditions Studied
Interventions
- DRUG IPX066 95 mg
- DRUG IPX066 145 mg
- DRUG IPX066 195 mg
- DRUG IPX066 245 mg
Study Locations (20)
Florida
- Bradenton Research Center, Inc. — Bradenton
- Sunrise Clinical Research — Hollywood
- Renstar Medical Research — Ocala
- Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida — Port Charlotte
- Suncoast Neuroscience Associates, Inc. — St. Petersburg
- University of South Florida, Parkinson's Disease and Movement Disorders Center — Tampa
California
- Coastal Neurological Medical Group — La Jolla
- Coordinated Clinical Research — La Jolla
- The Parkinson's Institute — Sunnyvale
- Collaborative NeuroScience Network, Inc. — Torrance
Arizona
- Mohammed Ali Parkinson's Center — Phoenix
- HOPE Research Institute — Phoenix
Illinois
- Northwestern University, Feinberg School of Medicine, Dept. of Neurology — Chicago
- Rush University Medical Center — Chicago
Alabama
- University of Alabama at Birmingham — Birmingham
Arkansas
- Clinical Trials Inc. — Little Rock
Georgia
- Medical College of Georgia, Movements Disorders Clinic — Augusta
Idaho
- Movement Disorder Center at Idaho Elks Rehabilitation Hospital — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01096186
The ClinicalTrials.gov registry entry for NCT01096186 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 617 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 4 interventions — of which IPX066 95 mg 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: NCT01096186 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Arizona. 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 NCT01096186 about?
NCT01096186 is a clinical study titled "An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease". The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
What is the current status of trial NCT01096186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2010-03. Estimated completion is 2011-10.
What conditions does trial NCT01096186 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 NCT01096186?
The interventions under investigation include: IPX066 95 mg (DRUG), IPX066 145 mg (DRUG), IPX066 195 mg (DRUG), IPX066 245 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01096186?
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 NCT01096186 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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