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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT00640159
Eligibility Criteria:
Inclusion Criteria:
1. Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity
2. Male or female outpatients
3. Age 30-90 years
4. Current use of levodopa and oral selegiline (5-10 mg /day), stable for at least 1 month and well tolerated
5. Positive treatment response to current anti-parkinsonian medications in the opinion of the investigator
6. Acceptable contraception for females of child bearing potential
7. Willing and able to comply with study procedures.
8. Willing and able to give written informed consent prior to beginning any study procedures.
Exclusion Criteria:
1. Atypical parkinsonism due to drugs, metabolic disorders, encephalitis, trauma, or other neurodegenerative diseases.
2. Significant cognitive or psychiatric impairment which, in the opinion of the investigator, would interfere with the ability to complete all the tests required in the protocol.
3. Participation in another clinical drug trial within the previous four weeks.
4. Patients on any medications contraindicated with Zelapar (including meperidine/Demerol, tramadol, methadone, propoxyphene, dextromethorphan, other selegiline products)
5. Patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar, or previous exposure to orally disintegrating selegiline
6. History of melanoma
7. Unstable/uncontrolled medical problems
8. History of drug/alcohol abuse
9. Patients currently taking rasagiline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT00640159
Study Brief:
Protocol Section:
NCT00640159