Back to resultsDouble Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
Primary Purpose
Levodopa-Induced Dyskinesia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tianqi Pingchan Granule
Tianqi Pingchan Granule Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Levodopa-Induced Dyskinesia
Eligibility Criteria
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
Sites / Locations
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tianqi Pingchan Granule group
Tianqi Pingchan Granule Placebo group
Arm Description
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.
placebo, granule, twice a day, for six months.
Outcomes
Primary Outcome Measures
new dyskinesia attack
The occurrence of Levodopa-Induced dyskinesia
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04173845
First Posted
November 5, 2019
Last Updated
November 20, 2019
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Nanjing University of Chinese Medicine, Xin Hua Hospital of Zhejiang Province, Suqian Branch, Jiangsu Province Hospital, Huai'an First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04173845
Brief Title
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of the Prevention of Levodopa-Induced Dyskinesia With Tianqi Pingchan Granule
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Nanjing University of Chinese Medicine, Xin Hua Hospital of Zhejiang Province, Suqian Branch, Jiangsu Province Hospital, Huai'an First People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Levodopa-Induced Dyskinesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tianqi Pingchan Granule group
Arm Type
Experimental
Arm Description
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.
Arm Title
Tianqi Pingchan Granule Placebo group
Arm Type
Placebo Comparator
Arm Description
placebo, granule, twice a day, for six months.
Intervention Type
Drug
Intervention Name(s)
Tianqi Pingchan Granule
Intervention Description
Tianqi Pingchan Granule are given twice a day
Intervention Type
Drug
Intervention Name(s)
Tianqi Pingchan Granule Placebo
Intervention Description
Tianqi Pingchan Granule Placebo
Primary Outcome Measure Information:
Title
new dyskinesia attack
Description
The occurrence of Levodopa-Induced dyskinesia
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
48 weeks
Title
Patient diaries
Description
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.
Time Frame
48 weeks
Title
MMSE（Mini-Mental State Examination）
Description
To assess the degree of cognitive impairment of patients. The score range is 0-30, where a higher score means more severe cognitive impariment.
Time Frame
48 weeks
Title
HAMA (Hamilton Anxiety Scale)
Description
To assess the severity of anxiety symptoms. The score range is 0-56, where a higher score means more severe anxiety symptoms.
Time Frame
48 weeks
Title
HAMD-24(Hamilton Depression Scale-24)
Description
To assess the severity of depression symptoms. The score range is 0-96, where a higher score means more severe depression symptoms.
Time Frame
48 weeks
Title
NMSQuest（Nonmotor symptoms Questionnaire）
Description
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.
Time Frame
48 weeks
Title
PDSS （Parkinson's Disease Sleep Scale）
Description
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.
Time Frame
48 weeks
Title
ESS （Epwroth Sleepiness Scale）
Description
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.
Time Frame
48 weeks
Title
SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)
Description
To assess the severity of autonomic symptoms. The score range is 0-104, where a higher score means more severe autonomic symptoms.
Time Frame
48 weeks
Title
PD-ADL（Parkinson's disease-Activity of Daily Living Scale）
Description
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.
Time Frame
48 weeks
Title
Clinical Global Impression
Description
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.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na Wu, MD
Phone
13524185616
Email
nanakingkitty@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenguo Liu, MD
Phone
8602125077501
Email
zhenguoliu2004@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenguo Liu, MD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Wu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
We'll reach out to this number within 24 hrs