Restless Legs Syndrome (RLS)
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is male or female, and is >=13 and =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 Are the trial subjects under 18? yes Number of subjects for this age range: 138 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week Maintenance Period;Secondary Objective: To investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS;Primary end point(s): 1. Change from Baseline to the end of the Maintenance Period in International Restless Legs Rating Scale (IRLS) sum score 2. Change from Baseline in Clinical Global Impressions (CGI) Item 1 to the end of the Maintenance Period 3. Percentage of participants with treatment-emergent adverse events (TEAEs) 4. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawals;Timepoint(s) of evaluation of this end point: 1.; 2. From Baseline to the end of the Maintenance Period (Day 78) 3.; 4. From Baseline to Safety Follow-Up (up to Week 20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in Restless Legs-6 Rating Scales (RLS-6) to the end of the Maintenance Period;Timepoint(s) of evaluation of this end point: From Baseline to the end of the Maintenance Period (Day 78) | — |
Countries
United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed