CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
Pioglitazone +1 moredrug
Likely dose
Pioglitazone 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01280123
NCT01280123Phase 2Completed
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A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease

University of Rochester·interventional·Posted Jan 20, 2011·Updated Oct 14, 2015

In Brief

A Phase 2 clinical trial evaluating Pioglitazone and placebo for Parkinson's Disease. Completed, enrolled 210 participants across 38 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Michael J. Fox Foundation for Parkinson's Research

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.5 years ago

Interventions

Pioglitazonedrug

Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated.

placebodrug

Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.