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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT00419692
Eligibility Criteria:
Inclusion criteria:
* Patients with a diagnosis of RLS
* Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
* Normal blood pressure pre-study
* Light smokers only (\<20/day)
Exclusion criteria:
* History of postural hypotension or faints
* Secondary RLS
* Patients who suffer from a primary sleep disorder other than RLS
* Patients diagnosed with movement disorders
* Patients with unstable medical conditions
* Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
* Patients with abnormal laboratory values
* Patients with hepatitis or HIV
* Patients who abuse alcohol or drugs
* Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00419692
Study Brief:
Protocol Section:
NCT00419692