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

Primary Purpose

L-DOPA-Induced Dyskinesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tianqi Pingchan Granule Combined With Amantadine
Placebo Combined With Amantadine
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for L-DOPA-Induced Dyskinesia

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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 Combined With Amantadine

placebo Combined With Amantadine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

First Posted
October 30, 2019
Last Updated
November 29, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Traditional Chinese Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Affiliated Hospital of Qingdao University, Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04173832
Brief Title
Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (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
Shanghai University of Traditional Chinese Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Affiliated Hospital of Qingdao University, Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
L-DOPA-Induced Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tianqi Pingchan Granule Combined With Amantadine
Arm Type
Experimental
Arm Title
placebo Combined With Amantadine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tianqi Pingchan Granule Combined With Amantadine
Intervention Description
Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
Intervention Type
Drug
Intervention Name(s)
Placebo Combined With Amantadine
Intervention Description
Placebo and Amantadine are given to patients simultaneously
Primary Outcome Measure Information:
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Patient diaries
Description
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.
Time Frame
up to 12 weeks
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 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.
Time Frame
up to 12 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
up to 12 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: PD patients between the ages of 30-85; Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points; 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; The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment; Levodopa is administered at least three times a day. Exclusion Criteria: PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia; pregnant and lactating women; Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment; Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points; Psychiatric symptoms associated with anti-Parkinson's disease drugs accompanied by a history of mental illness; impaired liver and kidney function; accompanied by severe other systemic diseases; Amantadine treatment has been received within the first 30 days of enrollment; History of medication with apomorphine or dopamine receptor antagonists; Previously taking amantadine, unable to tolerate; Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions; Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention. has received PD-related brain surgery; Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days; Patients who are unable to follow up with follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhang, MD
Phone
13916006909
Email
zhangyu0330@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenguo Liu, MD
Phone
8602125077501
Email
zhenguoliu2004@aliyun.com
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
Yu Zhang, Doctor
Phone
8613916006909
Email
zhangyu0330@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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