Restless Legs Syndrome | Switching From Oral Dopamine Agonists to Rotigotine
Restless Legs Syndrome research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Restless Legs Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RotigotineRotigotine 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Oral Dopamine Agonist to RotigotineDuring the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Start Date: August 2014
Completed Date: December 2015
Phase: Phase 4
Primary Outcome: Proportion of Patients Completing the Switch and Their Adverse Events
Secondary Outcome: International Restless Legs Scale (IRLS)
Study sponsors, principal investigator, and references
Lead Sponsor: John Winkelman, MD, PhD
Collaborator: UCB Pharma