A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine 1 milligram/24 hours; Rotigotine 2 milligram/24 hours; Placebo
Intervention description: Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: RLS; Rotigotine; Neupro

Summary:

      The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in
      adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance
      period and to investigate the safety and tolerability of rotigotine in adolescent subjects
      with idiopathic RLS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, and is >=13 and <18 years of age at Baseline

          -  Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or
             significant distress or impairment in social, occupational, educational, or other
             important areas of functioning by the impact on sleep, energy/vitality, daily
             activities, behavior, cognition or mood

          -  At Baseline, subject has a score of >=15 on the International Restless Legs Rating
             Scale (IRLS) (indicating moderate-to-severe RLS)

          -  At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1
             assessment (indicating at least moderately ill)

          -  Subjects who are receiving supplemental iron have been on a stable dose for at least 1
             month prior to Screening

          -  Female subjects must be surgically incapable of childbearing, or effectively
             practicing an acceptable method of contraception (oral/parenteral/implantable hormonal
             contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an
             acceptable method. Subjects must agree to use adequate contraception during the study
             and for 4 weeks after their final dose of study medication.

        Exclusion Criteria:

          -  Subject has a serum ferritin level below the lower limit of normal at Visit
             1/Screening

          -  Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening

          -  Subject has had previous treatment with dopamine agonists or L-dopa within 7 days
             prior to Visit 2/Baseline

          -  Subject has any medical or psychiatric condition, which in the opinion of the
             investigator, would jeopardize or compromise the subject's well-being or ability to
             participate in this study

          -  Subject is pregnant or nursing

          -  Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days
             prior to Visit 2/Baseline and for the duration of the study

          -  At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease
             of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood
             pressure (SBP) or of >=10 mmHg in diastolic

          -  Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency
             [uremia], iron deficiency, or rheumatoid arthritis)

          -  Subject has a lifetime history of suicide attempts (including actual attempt,
             interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6
             months as indicated by a positive response ("Yes") to either Question 4 or Question 5
             of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)

          -  Subject is taking a prohibited concomitant medication. Prohibited concomitant
             medication must have been discontinued at least 2 weeks prior to Screening (Visit 1)