Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04173832
• Collaborator: Shanghai University of Traditional Chinese Medicine (Other), Shanghai Municipal Hospital of Traditional Chinese Medicine (Other), Wenzhou Central Hospital (Other), The Affiliated Hospital of Qingdao University (Other), Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine (Other), The Affiliated Hospital of Xuzhou Medical University (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
L-DOPA-Induced Dyskinesia	Drug: Tianqi Pingchan Granule Combined With Amantadine; Drug: Placebo Combined With Amantadine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tianqi Pingchan Granule Combined With Amantadine	Drug: Tianqi Pingchan Granule Combined With Amantadine; Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
Placebo Comparator: placebo Combined With Amantadine	Drug: Placebo Combined With Amantadine; Placebo and Amantadine are given to patients simultaneously

Outcome Measures

Primary Outcome Measures

1. Unified Dyskinesia Rating Scale (UDysRS) [up to 12 weeks]

   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.

Secondary Outcome Measures

1. Patient diaries [up to 12 weeks]

   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.

2. Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [up to 12 weeks]

   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.

3. Clinical Global Impression [up to 12 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Shanghai University of Traditional Chinese Medicine
• Shanghai Municipal Hospital of Traditional Chinese Medicine
• Wenzhou Central Hospital
• The Affiliated Hospital of Qingdao University
• Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine
• The Affiliated Hospital of Xuzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04173832
• Other Study ID Numbers: XHEC-C-2019-032-2
• First Posted: Nov 22, 2019
• Last Update Posted: Dec 1, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyskinesias; Amantadine

Study Results

No Results Posted as of Dec 1, 2020