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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT00108667
Eligibility Criteria:
INCLUSION CRITERIA:
Patients who meet all of the following inclusion criteria on Study Day 1 will be eligible to participate in the study:
1. Between the ages of 21 and 80, inclusive;
2. Has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings;
3. Has relatively advanced disease with levodopa-associated motor response complications, including ratable peak-dose dyskinesias and wearing-off fluctuations;
4. Patient is willing to adhere to protocol requirements as evidenced by written, informed consent;
5. Patient is satisfactorily treated with levodopa with or without short acting dopamine agonist.
EXCLUSION CRITERIA:
Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately withdrawn from the study, as appropriate:
1. Has a history of any medical condition that can reasonably be expected to subject them to unwarranted risk, including lung disease, liver disease and clinically significant cardiac arrhythmias and/or myocardial ischemia;
2. Has clinically significant laboratory abnormalities including liver enzyme elevation; positivity to any of the autoantibodies tested at Screening (ANA, RF, anti-SM, anti-LKM)
3. Is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipexole or ropinirole;
4. Unable or unwilling to discontinue a prohibited concomitant medication as listed below; allowable CNS medications will be maintained at a constant dose throughout the study;
5. Has not been using an adequate contraceptive method for the last 30 days or unwilling to continue, or is not at least one year post-menopausal (if female);
6. Is pregnant or breastfeeding;
7. Is implanted with bilateral deep brain stimulators unless the stimulators are turned off during the entire study;
8. Has prior bilateral pallidotomy or other ablative surgeries for treatment of PD;
9. Has cognitive impairment (MMSE less than 25);
10. Has participated in a clinical study with an investigational drug within the last 30 days;
11. Has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety;
12. Is unwilling to sign an informed consent or to comply with protocol requirements.
13. Unilateral and bilateral pallidotomy
14. History of alcoholism.
15. Orthostatic Hypotension
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00108667
Study Brief:
Protocol Section:
NCT00108667