Pioglitazone in Early Parkinson's Disease
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.
Timeline
- Start
- 2011-03
- Primary completion
- 2014-05
- Completion
- 2014-05
Outcome
Missed primary endpoint
paper The null hypothesis could not be rejected (p=0·19). PMID 26116315 ↗
paper the null hypothesis was rejected in favour of futility (p=0·09). PMID 26116315 ↗
paper These findings suggest that pioglitazone at the doses studied here is unlikely to modify progression in early Parkinson's disease. PMID 26116315 ↗
Publications
- Results NINDS Exploratory Trials in Parkinson Disease (NET-PD) FS-ZONE Investigators. Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial. Lancet Neurol. 2015 Aug;14(8):795-803. doi: 10.1016/S1474-4422(15)00144-1. Epub 2015 Jun 23.
- Carta AR, Simuni T. Thiazolidinediones under preclinical and early clinical development for the treatment of Parkinson's disease. Expert Opin Investig Drugs. 2015 Feb;24(2):219-27. doi: 10.1517/13543784.2015.963195. Epub 2014 Sep 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pioglitazone | Small molecule | 15 mg | Oral |
| Subject | Pioglitazone | Small molecule | 45 mg | Oral |