A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
UCB Biopharma S.P.R.L.
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)

- If subject is receiving supplemental iron, subject has been on a stable dose for at
least 3 months 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 <50 ng/mL 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