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FOR THE INITIAL AND LONG-TERM TREATMENT OF PARKINSON'S DISEASE (PD)

In early Parkinson's disease, MIRAPEX significantly improves activities of daily living and motor scores

MIRAPEX monotherapy significantly improved everyday activities in as early as 3 weeks4

Change in UPDRS ADL Scores4

Monotherapy with Mirapex significantly improves UPDRS ADL scores

Shannon KM. Neurology, 1997.
Multicenter, randomized, double-blind, placebo-controlled, 31-week trial in 335 (333 analyzed) patients with early Parkinson's disease (Hoehn and Yahr stages I-III) who were not taking levodopa or amantadine. Objective: to assess the efficacy and safety of MIRAPEX. Dosing: patients were randomized to treatment with placebo or MIRAPEX titrated to ≤4.5 mg/day. Primary outcome variables were changes in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II (ADL) and III (motor) scores between baseline and the end of the maintenance period. Secondary outcome variables included changes in the baseline in the individual components of UPDRS, and in Hoehn and Yahr stages. Conclusion: this study confirms that MIRAPEX is safe and effective in the treatment of early Parkinson's disease.

 
 

Important Information about MIRAPEX: MIRAPEX is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD).

Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and postural (orthostatic) hypotension may occur. In clinical trials for early PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea (28% vs. 18%), dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia (14% vs. 12%), and constipation (14% vs. 6%). In clinical trials for advanced PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are postural hypotension (53% vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%), dizziness (26% vs. 25%), accidental injury (17% vs. 15%), hallucinations (17% vs. 4%), and dream abnormalities (11% vs. 10%).

Patients and caregivers should be informed that impulse control disorders and compulsive behaviors have been reported in patients taking dopamine agonists, including MIRAPEX.

Please see full Prescribing Information.

This information is intended for U.S. residents only.