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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 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 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 12 states.

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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.

Conditions Studied

Parkinson's Disease

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

FieldValue
Enrollment Target 210 participants
Start Date 2011-03
Est. Completion 2014-05
Phase Phase 2

Sponsor

University of Rochester

636 total trials

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What the Registry Record Tells You About NCT01280123

The ClinicalTrials.gov registry entry for NCT01280123 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (67% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.