Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.

Detailed Description
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The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of the Prevention of Levodopa-Induced Dyskinesia With Tianqi Pingchan Granule

Conditions
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Levodopa-Induced Dyskinesia

Intervention / Treatment
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* Drug: Tianqi Pingchan Granule
* Drug: Tianqi Pingchan Granule Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PD aged 30-85，have at least the following two conditions: Dosage of Levodopa ≥ 400mg/d; Grade of H&Y≥3; risk score of dyskinesia>4; Exclusion Criteria: PD patients with dyskinesia; Taking other Chinese medicines against Parkinson's disease; pregnant and lactating women; Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points; accompanied by a history of mental illness; impaired liver and kidney function; accompanied by severe other systemic diseases; Previous traditional Chinese medicine preparations or serious adverse reactions Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention. PD related brain surgery Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before Patients unable to cooperate with the survey

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tianqi Pingchan Granule group<br>Tianqi Pingchan Granule were manufactured according to Good Manufacturing Practice (GMP) by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. , granule, twice a day, for six months. | Drug: Tianqi Pingchan Granule<br>* Tianqi Pingchan Granule are given twice a day<br>|
| Placebo Comparator: Tianqi Pingchan Granule Placebo group<br>placebo, granule, twice a day, for six months. | Drug: Tianqi Pingchan Granule Placebo<br>* Tianqi Pingchan Granule Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new dyskinesia attack | The occurrence of Levodopa-Induced dyskinesia | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impariment. | 48 weeks | 
| Patient diaries | Change in daily OFF-time as assessed with patient diaries from run-in to 48 weeks. This is a self administerd diary where patients assess their motor state every half hour during 24 hours. | 48 weeks | 
| MMSE（Mini-Mental State Examination） | To assess the degree of cognitive impairment of patients. The score range is 0-30, where a higher score means more severe cognitive impariment. | 48 weeks | 
| HAMA (Hamilton Anxiety Scale) | To assess the severity of anxiety symptoms. The score range is 0-56, where a higher score means more severe anxiety symptoms. | 48 weeks | 
| HAMD-24(Hamilton Depression Scale-24) | To assess the severity of depression symptoms. The score range is 0-96, where a higher score means more severe depression symptoms. | 48 weeks | 
| NMSQuest（Nonmotor symptoms Questionnaire） | To assess the severity and frequency of non-motor symptoms of Parkinson's disease. The score range of severity and frequency is 0-90 respectively, where a higher score means more severe and frequent non-motor symptoms of Parkinson's disease. | 48 weeks | 
| PDSS （Parkinson's Disease Sleep Scale） | To assess the severity of sleep of Parkinson's disease patients. The score range is 0-150, where a higher score means more severe sleep disorders. | 48 weeks | 
| ESS （Epwroth Sleepiness Scale） | To assess excessive daytime sleepiness in patients with Parkinson's disease. The score range is 0-24, where a higher score means more severe sleep disorders. | 48 weeks | 
| SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms) | To assess the severity of autonomic symptoms. The score range is 0-104, where a higher score means more severe autonomic symptoms. | 48 weeks | 
| PD-ADL（Parkinson's disease-Activity of Daily Living Scale） | To assess the severity of Daily Living activity . The score range is 0-4, where a higher score means more severe daily living activity of Parkinson's disease patients. | 48 weeks | 
| Clinical Global Impression | Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with no change. | 48 weeks |