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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT05529095
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic RLS diagnosed by standard criteria, with an IRLS \> 15 while taking at least 1 RLS medication
* Stable RLS medications for at least 2 weeks prior to study entry
Exclusion Criteria:
* Concurrent untreated sleep disorders, not felt to be able stable
* Subjects with any significant, unstable cardiovascular, liver, lung, renal. psychiatric, or neurological diseases (not including RLS)
* Any medical or psychiatric comorbidity that, in the opinion of the investigator, would make study compliance difficult to achieve
* Intravenous iron within 4 weeks of study entry
* Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is a possibility (pre-menopausal, sexually active women)
* Subjects with previous allergic reaction to apomorphine or sulfate sensitivity
* Subjects currently taking 5HT3 antagonists
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT05529095
Study Brief:
Protocol Section:
NCT05529095