Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

Summary

1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing 2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER

Timeline

Start

2011-09

Primary completion

2012-08

Completion

2012-10

Publications

• Background Jenner P, Konen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018.
• Background Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262.
• Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7.

Drugs

Indications