Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03728933
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT03728933
Study Brief:
Protocol Section:
NCT03728933