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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT04173832
Eligibility Criteria:
Inclusion Criteria:
1. PD patients between the ages of 30-85;
2. Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
3. The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
4. The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
5. Levodopa is administered at least three times a day.
Exclusion Criteria:
1. PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
2. pregnant and lactating women;
3. Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
4. Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE \<24 points; primary education level \<20 points; illiterate \<17 points;
5. Psychiatric symptoms associated with anti-Parkinson's disease drugs
6. accompanied by a history of mental illness;
7. impaired liver and kidney function;
8. accompanied by severe other systemic diseases;
9. Amantadine treatment has been received within the first 30 days of enrollment;
10. History of medication with apomorphine or dopamine receptor antagonists;
11. Previously taking amantadine, unable to tolerate;
12. Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions;
13. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
14. has received PD-related brain surgery;
15. Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days;
16. Patients who are unable to follow up with follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT04173832
Study Brief:
Protocol Section:
NCT04173832