Efficacy

MIRAPEX offers effective relief as assessed by physicians (CGI-I)

72% of patients on MIRAPEX experienced significant symptom improvements²

IMPROVEMENT ON THE CGI-I SCALE*

75% of patients on the 0.25 mg dose of MIRAPEX responded to therapy*

*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."

MIRAPEX offers effective relief as assessed by patients (PGI)

MIRAPEX provides symptom improvements^2,3

IMPROVEMENT ON THE PGI-I SCALE^†

^†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 Patient Global Impression (PGI) scale, an assessment tool that measures the improvements/changes in symptoms as recorded by patients.

PGI responders are defined as patients who rated their overall condition as "much better" or "very much better" after treatment with MIRAPEX. PGI was a secondary endpoint with 12-week data capture as the only prespecified endpoint.

MIRAPEX demonstrated long-term improvements in RLS

79% of patients who responded to MIRAPEX maintained long-term improvements¹

• Nearly 4 out of 5 patients who responded to MIRAPEX after 6 months' treatment maintained response at 9 months vs only 15% of patients on placebo*

PROPORTION OF RESPONDERS WHO MAINTAINED RESPONSE ON THE CGI-I AND IRLS SCALES*

*After a 26-week, open-label treatment phase, responders on MIRAPEX were randomized to placebo or continuation of MIRAPEX for an extended 12-week observation period.

Responders are defined as those having assessments of  "very much improved" or "much improved" on the CGI-I and an IRLS total score of 15 or below.

MIRAPEX reduced the number of patients with the most severe RLS

In a subgroup analysis of 122 RLS patients classified as most severe on the CGI-S scale...^4†

77% of patients on MIRAPEX (n=93) were no longer classified as most severe at study end vs 48% on placebo (n=29)⁴

REDUCTION IN THE NUMBER OF PATIENTS CLASSIFIED AS MOST SEVERE (MARKEDLY, SEVERELY, AND MOST EXTREMELY ILL)^†

^†A 12-week, double-blind, randomized, placebo-controlled trial of fixed doses of pramipexole (0.25 mg/day, 0.5 mg/day, and 0.75 mg/day). Patients were titrated to their randomized dose over 3 weeks. Primary endpoints were patient ratings on symptom severity on the IRLS and clinician rating improvements on the CGI-I scale.

The subgroup analysis is based on the Clinical Global Impressions-Severity of illness (CGI-S) scale, a secondary endpoint in this study. The CGI-S is a clinician-rated assessment tool that rates symptom severity in 7 categories: "normal/not at all ill," "borderline ill," "mildly ill," "moderately ill," "markedly ill," "severely ill," and "most extremely ill."

Clinical Trials