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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT01071395
Eligibility Criteria:
Inclusion Criteria:
1. Parkinson's disease patient, defined by United Kingdom Brain Bank criteria
2. Current age between 30-90
3. Clinically pertinent dyskinesias defined by Clinical Gl;obal Impression-severity score (see attachment) \> 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. \*
4. Documentation of creatinine level at screening evaluation that is within the normal range for the local university laboratory.
5. Stable doses of all antiparkinsonian medications for at least 4 weeks
6. No treatment with amantadine for at least 3 months.
7. Presence of a caregiver willing to participate in the study
8. Subjects/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period (see attached training rules).
9. Subjects must be able to provide written informed consent.
10. If the subject received amantadine in the past, the drug was stopped for reason other than adverse events.
11. In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
12. The subject must be willing to participate in all study related activities and visits.
Exclusion Criteria:
1. Subjects who have had prior brain surgery.
2. Subjects with other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention.
3. Subjects with dementia, depression and psychosis as determined by clinical examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT01071395
Study Brief:
Protocol Section:
NCT01071395