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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02046434
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic Parkinson's disease with mild symptoms;
* May be on treatment with dopamine agonists provided that the treating neurologist agrees:
1. that the drugs can be stopped for at least three weeks prior to participating in the phenylbutyrate study, and
2. for the 4-week duration of the study.
* Age and sex matched normal control subjects from spouses and the general population;
* In good general health;
* Controlled hypertension, or
* Controlled hypercholesterolemia with medication.
Exclusion Criteria:
* Pregnant women;
* Current treatment with:
1. L-3,4-dihydroxyphenylalanine (L-DOPA);
2. monoamine oxidase (MAO) inhibitors,
3. catechol-O-methyl transferase (COMT) inhibitors;
4. histone deacetylase (HDAC) inhibitors;
5. prednisone or other corticosteroids, or
6. probenecid.
* Severe cardiopulmonary disease such as:
1. congestive heart failure, or
2. emphysema requiring supplemental oxygen;
* Renal disease with serum creatinine greater than 2.5;
* History of:
1. depression in the prior year;
2. epilepsy;
3. stroke;
4. prior brain surgery;
5. dementia, or
6. psychosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02046434
Study Brief:
Protocol Section:
NCT02046434