L-DOPA-Induced Dyskinesia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.
| Status | Recruiting |
| Enrollment | 100 |
| 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: 1. PD patients between the ages of 30-85; 2. Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score = 2 points; 3. The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour; 4. The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment; 5. Levodopa is administered at least three times a day. Exclusion Criteria: 1. PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia; 2. pregnant and lactating women; 3. Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment; 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. Psychiatric symptoms associated with anti-Parkinson's disease drugs 6. accompanied by a history of mental illness; 7. impaired liver and kidney function; 8. accompanied by severe other systemic diseases; 9. Amantadine treatment has been received within the first 30 days of enrollment; 10. History of medication with apomorphine or dopamine receptor antagonists; 11. Previously taking amantadine, unable to tolerate; 12. Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions; 13. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention. 14. has received PD-related brain surgery; 15. Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days; 16. Patients who are unable to follow up with follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Qingdao University, The Affiliated Hospital of Xuzhou Medical University, Wenzhou Central Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Unified Dyskinesia Rating Scale (UDysRS) | The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia. | up to 12 weeks | |
| Secondary | Patient diaries | Change in daily "OFF"-time as assessed with patient diaries from run-in to day 84. This is a self administered diary where patients assess their motor state every half hour during 24 hours. | up to 12 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 Baseline (Day 1) to day 84. 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 impairment. | up to 12 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 | up to 12 weeks |