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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00459420
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of idiopathic PD
* Excessive daytime somnolence (defined as an Epworth sleepiness scale score of \>10).
Exclusion Criteria:
* Estimated daily caffeine intake of more than 200 mg per day
* Active peptic ulcer disease
* Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter)
* Uncontrolled hypertension - defined as systolic bp \>170 or diastolic bp \>110 on two consecutive readings
* EDS is caused by sleep apnea, restless legs syndrome, narcolepsy, shift work, or sleep promoting agents.
* Current use of prescribed alerting agents such as modafinil and methylphenidate
* Pre-menopausal women who are not using effective methods of birth control
* Dementia, defined as MMSE \<24/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process
* Depression, as defined by a Beck Depression Inventory score of \>15.
* Changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00459420
Study Brief:
Protocol Section:
NCT00459420