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

NCT04173832 | Unknown

• 1 other identifier: XHEC-C-2019-032-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

L-DOPA-Induced Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient diaries

  up to 12 weeks

• Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  up to 12 weeks

• Clinical Global Impression

  up to 12 weeks

Study Arms (2)

Tianqi Pingchan Granule Combined With Amantadine

EXPERIMENTAL

Drug: Tianqi Pingchan Granule Combined With Amantadine

placebo Combined With Amantadine

PLACEBO COMPARATOR

Drug: Placebo Combined With Amantadine

Interventions

Tianqi Pingchan Granule Combined With Amantadine DRUG

Tianqi Pingchan Granule and Amantadine are given to patients simultaneously

Tianqi Pingchan Granule Combined With Amantadine

Placebo Combined With Amantadine DRUG

Placebo and Amantadine are given to patients simultaneously

placebo Combined With Amantadine

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

• Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024 Sep;22(5):545-551. doi: 10.1016/j.joim.2024.07.002. Epub 2024 Jul 9.

  PMID: 39060125 DERIVED

MeSH Terms

Interventions

Amantadine

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yu Zhang, MD

CONTACT

13916006909; zhangyu0330@126.com

Zhenguo Liu, MD

CONTACT

8602125077501; zhenguoliu2004@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)