Clinical trial NCT04173832: Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: L-DOPA-Induced Dyskinesia
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Wenzhou Central Hospital
name: The Affiliated Hospital of Qingdao University
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2019-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.


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.

Primary outcomes:
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Patient diaries
timeFrame: up to 12 weeks
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: up to 12 weeks
measure: Clinical Global Impression
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: