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NCT01280123 · ClinicalTrials.gov registry record · Phase 2
Pioglitazone in Early Parkinson's Disease
A Phase 2 study of Parkinson's Disease, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT01280123: Completed Phase 2 study of Parkinson's Disease, sponsored by University of Rochester.
NCT01280123 is a Phase 2 study of Parkinson's Disease that has completed, run by University of Rochester. The registered enrollment target is 210 participants, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280123, a Phase 2 study of Parkinson's Disease, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day). The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes. The change is 44 weeks - baseline.
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 |
What the finished NCT01280123 record still lists
NCT01280123 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (67% lower).
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.
NCT01280123 names 20 study sites across 12 states, led by Florida, California, Georgia.
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.
What interventions are being tested in trial NCT01280123?
The interventions under investigation include: placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01280123?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01280123's enrollment target sits among peer trials
210 32nd of 158 higher than 127 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease 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.
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