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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00867893
Eligibility Criteria:
Inclusion Criteria:
1. Primary RLS (exclude all secondary RLS including those related to neuropathies and medications)
2. Adult and adolescents 18 years of age or older
3. One of the following 2 criteria must be met:
* RLS treatment with either ropinirole or pramipexole or with a non-DA treatment (opioid or GABA active hypnotic), with the first dose each day taken at or before 4:30 PM. (Note this allows patients to be entered who had the usual tapered withdrawal from another medication with a concurrent gradual start of the DA agonist or opioid over a period of up to 12 months. In all such cases the initial evaluations must occur at least 6 weeks after discontinuing any prior drug treatment.) OR
* Off all RLS medication treatments for at least 6 weeks AND planning on starting DA agonist or a non-DA treatment (opioid or GABA active hypnotic) as the only RLS medication treatment.
Exclusion Criteria:
1. Pregnant or lactating.
2. Inadequate birth control if female and able to become pregnant.
3. History of allergic reaction to diphenhydramine.
4. History of major psychiatric or chronic neurological disorder that would affect RLS treatment or judgment. These include but are not limited to bipolar depression, major affective disorder, schizophrenia, obsessive-compulsive disorder, and all neurodegenerative diseases.
5. History of another major sleep disorder other than RLS and insomnia: narcolepsy, significant sleep-disordered breathing (DBR\>15/hr), and circadian rhythm disorder.
6. History of use of dopamine antagonist within the last year for any reason other than treating nausea.
7. History of use of tramadol within the last 3 months.
8. Unable to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00867893
Study Brief:
Protocol Section:
NCT00867893