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

Launched by UCB BIOPHARMA SRL · Oct 31, 2018

Keywords

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Gender

ALL

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)