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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02439203
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.
* All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.
* Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.
* Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).
Exclusion Criteria:
* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.
* History of any other brain surgery or surgery for the treatment of PD.
* Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
* A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).
* A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.
* Clinically significant abnormal laboratory data at screening.
* Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP1.
* History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.
* History of serotonin syndrome.
* Breast feeding or pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02439203
Study Brief:
Protocol Section:
NCT02439203