Last updated: November 29, 2020
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dyskinesias
Treatment
N/AClinical Study ID
NCT04173832
XHEC-C-2019-032-2
Ages 30-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- PD patients between the ages of 30-85;
- Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
- The patient diary shows that there are at least two opening periods between 9 am and 4pm every day, and the dyskinesia appears in the opening period, each time lasting morethan half an hour;
- The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30days before enrollment;
- Levodopa is administered at least three times a day.
Exclusion
Exclusion Criteria:
- PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
- pregnant and lactating women;
- Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
- Impaired cognitive function (according to pre-entry MMSE score): secondary educationlevel: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- Psychiatric symptoms associated with anti-Parkinson's disease drugs
- accompanied by a history of mental illness;
- impaired liver and kidney function;
- accompanied by severe other systemic diseases;
- Amantadine treatment has been received within the first 30 days of enrollment;
- History of medication with apomorphine or dopamine receptor antagonists;
- Previously taking amantadine, unable to tolerate;
- Allergic to the amantadine, memantine, and traditional Chinese medicine preparationsor serious adverse reactions;
- Before the enrollment, the EKG showed obvious abnormalities and required clinicalintervention.
- has received PD-related brain surgery;
- Patients who are participating in other clinical studies or have participated in otherclinical studies within the previous 30 days;
- Patients who are unable to follow up with follow-up.
Study Design
Total Participants: 100
Study Start date:
January 01, 2020
Estimated Completion Date:
December 31, 2021
Connect with a study center
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200092
ChinaActive - Recruiting

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