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

Not Applicable

• Conditions: Levodopa-Induced Dyskinesia
• Interventions: Drug: Tianqi Pingchan Granule; Drug: Tianqi Pingchan Granule Placebo

• Registration Number: NCT04173845
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients with PD aged 30-85，have at least the following two conditions:

1. Dosage of Levodopa ≥ 400mg/d;
2. Grade of H&Y≥3;
3. risk score of dyskinesia>4;

Exclusion Criteria

1. PD patients with dyskinesia;

2. Taking other Chinese medicines against Parkinson's disease;

3. pregnant and lactating women;

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. accompanied by a history of mental illness;

6. impaired liver and kidney function;

7. accompanied by severe other systemic diseases;

8. Previous traditional Chinese medicine preparations or serious adverse reactions

9. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.

10. PD related brain surgery

11. Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before

12. Patients unable to cooperate with the survey

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tianqi Pingchan Granule group	Tianqi Pingchan Granule	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.
Tianqi Pingchan Granule Placebo group	Tianqi Pingchan Granule Placebo	placebo, granule, twice a day, for six months.

Primary Outcome Measures

Name	Time	Method
new dyskinesia attack	48 weeks	The occurrence of Levodopa-Induced dyskinesia

Secondary Outcome Measures

Name	Time	Method
HAMA (Hamilton Anxiety Scale)	48 weeks	To assess the severity of anxiety symptoms. The score range is 0-56, where a higher score means more severe anxiety symptoms.
HAMD-24(Hamilton Depression Scale-24)	48 weeks	To assess the severity of depression symptoms. The score range is 0-96, where a higher score means more severe depression symptoms.
ESS （Epwroth Sleepiness Scale）	48 weeks	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.
SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)	48 weeks	To assess the severity of autonomic symptoms. The score range is 0-104, where a higher score means more severe autonomic symptoms.
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	48 weeks	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.
PD-ADL（Parkinson's disease-Activity of Daily Living Scale）	48 weeks	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.
Patient diaries	48 weeks	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.
MMSE（Mini-Mental State Examination）	48 weeks	To assess the degree of cognitive impairment of patients. The score range is 0-30, where a higher score means more severe cognitive impariment.
NMSQuest（Nonmotor symptoms Questionnaire）	48 weeks	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.
PDSS （Parkinson's Disease Sleep Scale）	48 weeks	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.
Clinical Global Impression	48 weeks	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.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China