A randomized, double-blind, active (pramipexole 0.5 mg tid) and placebo controlled, efficacy study of pramipexole given 0.5 mg and 0.75 mg bid over a 12-week treatment phase in early Parkinson’s disease patients (PramiBID)
This clinical trial investigated the dopamine agonist pramipexole (Mirapex®). At the time of this study in 2007, Pramipexole was generally taken 3 times each day and taking more than 1mg daily to treat symptoms of early PD. The purpose of the study was to determine if the medication would be effective with less frequency and at lower dosages.
The primary objective of this study was to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives were to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo, and also to compare tolerability among the treatment groups over 12 weeks. Efficacy was measured by the change in the total Unified Parkinson’s Disease Rating Scale (UPDRS) Parts I-III score from baseline to week 12. These measures addresses motor and non-motor symptoms in the disease.
There were four treatment groups, 0.5 mg bid, 0.75 mg bid, 0.5 mg tid (active control), and placebo. All subjects took their treatment 3 times each day. The 12-week trial consisted of a 4-week titration phase and an 8-week maintenance phase.
The results showed that administering pramipexole twice daily in daily doses of 1-1.5mg was similarly effective as taking the higher (1.5mg total daily) and more frequent (3 times each day) standard dose. Abstract for article on pubmed