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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01283594
Eligibility Criteria:
Inclusion Criteria:
* Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-parkinson medications
* Are able to complete a Parkinson's disease diary
* If of childbearing potential(male and female), use an acceptable method of birth control
* Able and willing to sign an IRB/IEC approved informed consent
* Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.
Exclusion Criteria:
* Secondary or atypical Parkinson's
* Neurosurgical intervention for Parkinson's disease
* Treatment with apomorphine
* Treatment with anti-psychotic drugs
* Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
* MMSE less than 26
* Subjects with untreated or uncontrolled current episode of major depression
* Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \<100mg per day)
* Women pregnant or lactating
* History of hepatitis, cholangitis
* Untreated or uncontrolled hypothyroidism or hyperthyroidism
* Drops in blood pressure requiring medication to maintain blood pressure
* Any clinically significant out of range laboratory evaluations
* Known sensitivity to the study medication or its components
* Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
* Finding of malignant melanoma on full body skin exam
* Impulse disorder conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT01283594
Study Brief:
Protocol Section:
NCT01283594