Efficacy of MIRAPEX

Type sizer A A

The efficacy of MIRAPEX in the treatment of moderate-to-severe primary RLS was demonstrated in 4 clinical trials.

Efficacy in these trials was measured by:

The mean change in the International Restless Legs Scale (IRLS)
- The IRLS is an internationally validated scale accepted as the standard instrument for evaluation of the severity of RLS symptoms.¹²
- Consists of 10 subscales that measure symptom frequency/intensity and impact of symptoms on daily life and sleep¹²
- The range of the scale is from 0 to 40, with 0 being no RLS symptoms and 40 representing the most severe RLS symptoms¹²
The percentage of responders measured by Clinical Global Impressions-Improvement (CGI-I) scale
- The CGI-I measures overall clinical improvement.² A CGI-I responder is defined as someone who is rated by the CGI-I as "very much improved" or "much improved"

In these various trials:

Patients on MIRAPEX reached significant superiority compared with placebo for mean total IRLS score from baseline
The percentage of CGI-I responders was significantly higher in patients taking MIRAPEX compared with placebo
MIRAPEX showed sustained efficacy for the treatment of RLS for a period up to 9 months

Mean Total IRLS Score Change From Baseline^*†

^†As measured on the International Restless Legs Scale (IRLS), an internationally validated scale that is the standard instrument for evaluation of severity of RLS. The IRLS contains 10 subscale items; total score ranges from 0 to 40, with 0 being absence of RLS symptoms and 40 the most severe symptoms.

Percentage of CGI-I Responders Adjusted From Baseline*

*Results of a 12-week, placebo-controlled, randomized, double-blind, fixed-dose-treatment trial to assess the efficacy and safety of MIRAPEX vs placebo in the treatment of moderate-to-severe primary RLS. As measured on the Clinical Global Impressions-Improvement (CGI-I) scale, widely accepted for measuring improvement in RLS symptoms on a 7-point scale.

Responders are defined as those having assessments of "very much improved" or "much improved."

Efficacy

Healthcare professionals and patients agree?MIRAPEX can help relieve the symptoms of primary Restless Legs Syndrome (RLS). Learn more

Important information about prescribing MIRAPEX to your patients.

IMPORTANT SAFETY INFORMATION ABOUT MIRAPEX: MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

MIRAPEX may cause patients to fall asleep without any warning, even while doing normal daily activities, such as driving. When taking MIRAPEX, hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness. Patients should talk with their doctor if they experience these problems.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease and RLS.

This information is intended for U.S. residents only. Products discussed herein may have different labeling in different countries.

Please see full Prescribing Information, including patient information.