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:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01494766
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 18 to 80 years and
2. Newly diagnosed (medication-naïve) as having restless legs syndrome (using the International Restless Legs Syndrome Study Group (IRLSSG20) diagnostic criteria with a score of greater than or equal to 15, see Appendix A) and
3. That interfered with sleep onset and/or maintenance for greater than four nights/week for a minimum of six months
4. Currently not receiving treatment for RLS
Exclusion Criteria:
1. Patients suffering from secondary RLS (other movement and/or primary sleep disorders, chronic renal insufficiency - calculated from the creatinine clearance, and/or iron deficiency - baseline serum ferritin level less than 10 ng/ml)
2. Patients currently on pharmacotherapy for RLS (not medication-naïve) or previous use of pharmacotherapy for RLS in the past
3. Patients that are pregnant and/or breastfeeding
4. Patients that are on levothyroxine or monoamine oxidase inhibitors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01494766
Study Brief:
Protocol Section:
NCT01494766