Clinical Trials
A multinational drug development program, including approximately 1000 patients with moderate-to-severe primary RLS, was used to evaluate the efficacy of MIRAPEX.9
Overall design of the 2 pivotal trials
- Participation was limited to patients with moderate-to-severe primary restless legs syndrome. Patients with secondary RLS (caused by anemia, iron deficiency, pregnancy, etc) were excluded from the trials
- The trials were randomized, double-blind, and placebo-controlled
- Patients were administered MIRAPEX (0.125 mg, 0.25 mg, 0.5 mg, or 0.75 mg) or placebo once daily 2 to 3 hours before going to bed
- Patient progress was measured by using:
- The International Restless Legs Scale (IRLS)
- The Clinical Global Impressions-Improvement (CGI-I) scale
The first pivotal trial studied efficacy by comparing fixed doses (0.25, 0.50, 0.75 mg/day) of MIRAPEX to placebo over a treatment period of 12 weeks. The primary outcome measures for this trial were mean improvement from baseline on the IRLS and the percentage of patients that qualified as CGI-I responders. A CGI-I responder was defined as a patient who was rated using the CGI-I as "much improved" or "very much improved."
All treatment groups had statistically significant improvement compared to placebo for both endpoints (Table 1).
CGI-I responders = "much improved" and "very much improved"
The second pivotal trial demonstrated sustained efficacy of MIRAPEX for the treatment of restless legs syndrome for a period of up to 9 months. Patients were selected from a 6-month open-label trial of MIRAPEX using the following criteria:
- They had a CGI-I rating of "very much improved" or "much improved"
- They had an IRLS score of 15 or below
These selected patients were then randomized to receive either blinded active treatment at an individually optimized dose (n=78) or placebo (n=69) for 12 weeks. The primary endpoint of the trial was time to treatment failure based on a CGI-I score of "minimally worse" to "very much worse" and an IRLS total score above 15. Patients that responded to MIRAPEX treatment and were then randomized to the placebo group experienced a rapid worsening of their RLS symptoms. At the week 12 endpoint, 85% of the patients receiving placebo had failed treatment, compared to 21% treated with blinded MIRAPEX (P<0.0001).
Most patients who take MIRAPEX for moderate-to-severe primary restless legs syndrome (RLS) tolerate it well.
Most patients who take MIRAPEX for moderate-to-severe primary restless legs syndrome (RLS) tolerate it well. Learn more
Learn more about clinical evaluation when making a diagnosis of Restless Legs Syndrome (RLS)
Learn more about clinical evaluation [link to: 9.1] when making a diagnosis of Restless Legs Syndrome (RLS)
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.
