Switching From Oral Dopamine Agonists to Rotigotine
Condition: Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine
Intervention description: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease; Rotigotine; Neupro; Dopamine Agonist

Summary:

      The primary objective is to demonstrate safety and tolerability of switching patients with
      Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.

      As a secondary objective, the investigators will evaluate control of RLS symptoms on
      rotigotine compared to the prior oral regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RLS, defined by International Restless Legs Study Group (IRLS)
             essential criteria:

               1. An urge to move the legs, usually accompanied or caused by uncomfortable and
                  unpleasant sensations in the legs.

               2. The urge to move or unpleasant sensations begin or worsen during periods of rest
                  or inactivity such as lying down or sitting.

               3. The urge to move or unpleasant sensations are partially or totally relieved by
                  movement, such as walking or stretching, at least as long as the activity
                  continues.

               4. The urge to move or unpleasant sensations are worse in the evening or night than
                  during the day or only occur in the evening or night.

        (Although some subjects may not meet these criteria on their current oral regimen, these
        symptoms must have been present prior to treatment.)

          -  Current treatment with either pramipexole (≤1 mg total daily dose) or ropinirole (≤4
             mg total daily dose) with unchanged dose for the past 30 days. Patients also on other
             RLS medications will be allowed to participate if the dosing has been stable for the
             past 30 days and the subject agrees to maintain a stable dose for the duration of the
             trial.

          -  Inadequate symptom control or patient dissatisfaction with current oral regimen.

          -  Able to speak and read English.

          -  Able to provide informed consent.

          -  Able to learn and demonstrate appropriate patch application.

          -  Returns appropriately completed RLS symptom log at Visit 2.

          -  Confirms understanding of cross-titration schedule and is able to restate or summarize
             these instructions at Visit 2.

          -  Age ≥18 and ≤75.

          -  BMI ≥18 and ≤35

          -  History and/or clinical records document no change in medications active in the
             central nervous system (antidepressants, analgesics, antipsychotics, antiepileptics,
             hypnotics, etc.) for at least 30 days prior to visit 1.

          -  Able to understand study procedures and agrees to remain on stable medications during
             the period of the study.

          -  Women of childbearing potential must agree to use a medically accepted method of birth
             control. Acceptable forms of birth control include:

               1. Condom + spermicide

                    -  b. Diaphragm + spermicide

                    -  c. Oral contraceptive pills, hormone implants (like Norplant),or injections
                       (like Depo-Provera)

                    -  Intrauterine Device

        Exclusion Criteria:

          -  Known secondary cause of RLS, including end-stage renal disease, severe iron
             deficiency (ferritin <18), pregnancy.

          -  History of frequent symptomatic orthostatic hypotension.

          -  Current treatment with a dopamine antagonist medication.

          -  Another chronic pain syndrome that would, in the opinion of the investigator,
             interfere with evaluation of RLS symptoms or the response to the study medication.

          -  Plan to undergo a procedure that may require short or long-term opiates for pain
             control during the course of the trial.

          -  Women who are pregnant, lactating, or planning to become pregnant.

          -  Shift work or other commitments that do not allow for regular sleep at night.

          -  Known hypersensitivity or intolerance to rotigotine.

          -  Known allergy to sulfite-containing drugs.

          -  History of problematic skin hypersensitivity to adhesives.

          -  Previous or current clinically significant impulse control disorder, as determined by
             clinical interview.

          -  Anticipated change in psychiatric or neurologic status likely to require adjustment of
             CNS-active medications during the study period.

          -  Unwillingness of subject to remain on stable doses of CNS-active medications.

          -  Unwillingness of subject to refrain from as-needed use of RLS medications.

          -  Significant risk for suicide by clinical interview.

          -  History of severe mental illness or psychosis

          -  Current unstable medical illness.

          -  Any medical or psychiatric condition that, in the opinion of the investigator, would
             interfere with participation in the study.