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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT03083132
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic PD on UK brain bank criteria.
* Presence of FOG based on objective assessment by the movement disorders neurologist.
* FOG-Q score \> 8.
* Stable PD therapy (including medications and stimulation) for a period of 3 months prior to trial enrollment.
* Age ≥ 50 years.
Exclusion Criteria:
* Patients on antidopaminergic medications for a period of less than 1 year from date of enrollment.
* Patients who may require adjustment of their PD medications over the 6 month period of the trial.
* History of allergic reactions to Modafinil or armodafinil.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, mitral valve prolapse, left ventricular hypertrophy, chronic obstructive pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements.
* Individuals who are pregnant or breastfeeding
* Non-english speaking individuals who are unable to complete the questionnaires and other assessments in English and/or follow instructions in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT03083132
Study Brief:
Protocol Section:
NCT03083132