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

Levodopa-Induced Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173845
• Other study ID #: XHEC-C-2019-033-2
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Na Wu, MD
• Phone: 13524185616
• Email: nanakingkitty[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Levodopa-Induced Dyskinesia

Intervention

Drug:
• Tianqi Pingchan Granule
Tianqi Pingchan Granule are given twice a day
• Tianqi Pingchan Granule Placebo
Tianqi Pingchan Granule Placebo

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Huai'an First People's Hospital, Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, Suqian Branch, Jiangsu Province Hospital, Xin Hua Hospital of Zhejiang Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new dyskinesia attack	The occurrence of Levodopa-Induced dyskinesia	48 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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