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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00314860
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
* Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Exclusion criteria:
* Signs of secondary RLS.
* Primary sleep disorder or movement disorder other than RLS.
* Unstable medical conditions.
* Inability to tolerate dopamine agonists or dopamine antagonists.
* Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00314860
Study Brief:
Protocol Section:
NCT00314860