Levodopa-Induced Dyskinesia
Conditions
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.
Interventions
DRUGTianqi Pingchan Granule
Tianqi Pingchan Granule are given twice a day
DRUGTianqi Pingchan Granule Placebo
Tianqi Pingchan Granule Placebo
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Xin Hua Hospital of Zhejiang Province
Suqian Branch, Jiangsu Province Hospital
Huai'an First People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| new dyskinesia attack | 48 weeks | The occurrence of Levodopa-Induced dyskinesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactNa Wu, MD
Backup ContactZhenguo Liu, MD
Outcome results
None listed