A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country100 target enrollmentJanuary 1, 2020

ConditionsL-DOPA-Induced Dyskinesia

InterventionsTianqi Pingchan Granule Combined With Amantadine Placebo Combined With Amantadine

DrugsTianqi Pingchan Granule Combined With Amantadine Placebo Combined With Amantadine

Overview

Phase: Not Applicable
Intervention: Tianqi Pingchan Granule Combined With Amantadine
Conditions: L-DOPA-Induced Dyskinesia
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment: 100
Locations: 1
Primary Endpoint: Unified Dyskinesia Rating Scale (UDysRS)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
•The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
•Levodopa is administered at least three times a day.

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 education level: 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;

Arms & Interventions

Tianqi Pingchan Granule Combined With Amantadine

Intervention: Tianqi Pingchan Granule Combined With Amantadine

placebo Combined With Amantadine

Intervention: Placebo Combined With Amantadine

Outcomes

Primary Outcomes

Unified Dyskinesia Rating Scale (UDysRS)

Time Frame: up to 12 weeks

The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.