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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT01725802
Eligibility Criteria:
Main Inclusion Criteria:
* Men and women with idiopathic Parkinson's disease
* Subjects must experience motor fluctuations associated with LD/CD dosing
* Modified Hoehn and Yahr stage \< 5
* Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
* Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
* Subjects must be age 30 or older.
* Subjects must be willing and able to give informed consent.
Main Exclusion Criteria:
* Subjects with a clinically significant or unstable medical or surgical condition
* Subjects with clinically significant psychiatric illness.
* Pre-menopausal women, not using birth control method.
* Subjects who have taken experimental medications within 60 days prior to baseline.
* Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01725802
Study Brief:
Protocol Section:
NCT01725802