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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03624920
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
* Subjects with Hoehn and Yahr scale score ≤ 4.
* Body mass index \> 18 kg/m2 and \< 35 kg/m2.
* Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).
* Epworth Sleepiness Scale (ESS) score ≥ 14.
Exclusion Criteria:
* Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
* Psychiatric and neurological disorders (other than Parkinson's disease),
* Cardiovascular disorders such as - but not limited to
* Uncontrolled moderate to severe hypertension
* History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
* Recent myocardial infarction
* Stable or unstable angina pectoris
* Cardiac insufficiency or history of heart failure
* Previous history of cardiac valvular surgery
* Subjects with current impulse control disorder.
* Subjects showing dementia or with MoCA \< 23.
* Subjects with current suicidal risk
* Current or recent (within one year) history of substance abuse or dependence disorder
* Other active clinically significant illness
* Subjects with hepatic or renal impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03624920
Study Brief:
Protocol Section:
NCT03624920