Clinical Evaluation
Determining a diagnosis for RLS
In recent years, a variety of rating scales have been applied to assess the severity of the broad range of RLS symptoms and improvement on therapy. Two scales in particular are consistently used to evaluate response to treatment for RLS:
- The International Restless Legs Scale
- The Clinical Global Impressions Scale
Further information about the background and use of these metrics can be found by clicking on the individual scales.
The International Restless Legs Scale (IRLS)
The IRLS, a fully validated rating scale developed by the International Restless Legs Syndrome Study Group, has become a standard instrument for evaluating the severity of RLS symptoms in a clinical trial setting.12
The IRLS clinically assesses symptom severity and evaluates efficacy of treatment in RLS. It addresses 10 RLS characteristics: 5 that pertain to symptom frequency and intensity and 5 that pertain to the impact of symptoms on daily life and sleep. Scores for each question range from 0 to 4, with 0 correlating to the answer "none" and 4 correlating to the answer "very severe."11,12
The Clinical Global Impressions (CGI) scale
The CGI scale is a widely used and standardized clinician-rated scale utilized in a clinical trial setting in many therapeutic areas to assess the effect of a drug treatment on a patient's overall condition. Improvement is based on the clinical difference between the patient's current condition (during treatment) and that prior to the start of treatment. The CGI scale consists of four subscales: severity, global improvement, therapeutic efficacy, and side effects.
The global improvement subscale, the CGI-Improvement (CGI-I) scale, in particular, is commonly used to rate a patient's overall improvement. Clinicians make their assessment by interviewing the patient and rely on the patient's description of his or her symptoms. The patient's level of global improvement is rated on a 7-point scale.13
Important information about prescribing MIRAPEX to your patients.
Important information about prescribing MIRAPEX to your patients.MIRAPEX has no predicted P450 interactions9an important consideration in patients on multiple medications
MIRAPEX has no predicted P450 interactions an important consideration in patients on multiple medications
MIRAPEX has no predicted P450 interactions an important consideration in patients on multiple medicationsMIRAPEX has no predicted P450 interactions9an important consideration in patients on multiple medications
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.
