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

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.

Study Overview

• Status: Unknown
• Conditions: L-DOPA-Induced Dyskinesia
• Intervention / Treatment: Drug: Tianqi Pingchan Granule Combined With Amantadine; Drug: Placebo Combined With Amantadine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Zhang, MD; Phone Number: 13916006909; Email: zhangyu0330@126.com
• Study Contact Backup: Name: Zhenguo Liu, MD; Phone Number: 8602125077501; Email: zhenguoliu2004@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: The Affiliated Hospital of Qingdao University; Shanghai University of Traditional Chinese Medicine; Wenzhou Central Hospital; The Affiliated Hospital of Xuzhou Medical University; Nanjing University of Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: XHEC-C-2019-032-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No