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Pioglitazone in Early Parkinson's Disease
NCT01280123 · View on ClinicalTrials.gov ↗
Study Summary
This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility. Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo. The study will measure disease progression by the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Pioglitazone
Study Locations (20)
Florida
- University of Florida — Gainsville
- University of Florida, Jacksonville — Jacksonville
- University of Miami — Miami
- University of South Florida — Tampa
California
- The Parkinson's & Movement Disorder Institute — Fountain Valley
- University of Southern California — Los Angeles
- University of California San Fransisco — San Francisco
Georgia
- Emory University School of Medicine — Atlanta
- Medical College of Georgia — Augusta
Illinois
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
Louisiana
- Ochsner Clinic Foundation — New Orleans
- LSU Health Science Center Shreveport — Shreveport
Alabama
- Univeristy of Alabama at Birmingham — Birmingham
Arizona
- Barrow Neurological Institute — Phoenix
Colorado
- Univeristy of Colorado Denver — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01280123
The ClinicalTrials.gov registry entry for NCT01280123 describes a study currently listed as completed. It is categorized as Phase 2, 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 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 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 placebo 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: NCT01280123 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Georgia. 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 NCT01280123 about?
NCT01280123 is a clinical study titled "Pioglitazone in Early Parkinson's Disease". This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility. Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no mor...
What is the current status of trial NCT01280123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2011-03. Estimated completion is 2014-05.
What conditions does trial NCT01280123 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 NCT01280123?
The interventions under investigation include: placebo (DRUG), Pioglitazone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01280123?
This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01280123 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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