Clinical trial NCT04173845: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Levodopa-Induced Dyskinesia
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Xin Hua Hospital of Zhejiang Province
name: Suqian Branch, Jiangsu Province Hospital
name: Huai'an First People's Hospital
First posted: 2019-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: new dyskinesia attack
timeFrame: 48 weeks
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 48 weeks
measure: Patient diaries
timeFrame: 48 weeks
measure: MMSE（Mini-Mental State Examination）
timeFrame: 48 weeks
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: 48 weeks
measure: HAMD-24(Hamilton Depression Scale-24)
timeFrame: 48 weeks
measure: NMSQuest（Nonmotor symptoms Questionnaire）
timeFrame: 48 weeks
measure: PDSS （Parkinson's Disease Sleep Scale）
timeFrame: 48 weeks
measure: ESS （Epwroth Sleepiness Scale）
timeFrame: 48 weeks
measure: SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)
timeFrame: 48 weeks
measure: PD-ADL（Parkinson's disease-Activity of Daily Living Scale）
timeFrame: 48 weeks
measure: Clinical Global Impression
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhenguo Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: