Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)

• Register: ChiCTR
• Last refreshed on: 11 June 2019
• Main ID: ChiCTR1900023725
• Date of registration: 2019-06-09
• Prospective Registration: Yes
• Primary sponsor: Zhujiang Hospital of Southern Medical University
• Public title: Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)
• Scientific title: Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)
• Date of first enrolment: 2019-08-01
• Target sample size: PD-Placebo:50;PD-Butylphthalide:50;VP-Placebo:50;VP-Butylphthalide:50;MSA-Placebo:50;MSA-Butylphthalide :50;PSP-Placebo:50;PSP-Butylphthalide:50;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=39890
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Dennis Qing Wang
• Affiliation: Zhujiang Hospital of Southern Medical University

• Name: Shuzhen Zhu
• Affiliation: Zhujiang Hospital of Southern Medical University

Key inclusion & exclusion criteria

Inclusion criteria: (1) Parkinson's disease (PD) was clinically diagnosed according to the clinical diagnostic criteria of the International Society for Motor Disability (MDS) in 2015.
(2) Complying with the diagnostic criteria of vascular Parkinson's syndrome proposed by Zijlmans et al. in 2004 and the diagnostic criteria agreed by experts in diagnosis and treatment of vascular Parkinson's syndrome formulated by Parkinson's Disease and Dyskinesia Group of Neurological Society of Chinese Medical Association in 2017;
(3) Complying with the second edition of MSA diagnostic criteria revised by Gilman in 2008;
(4) It conforms to the clinical diagnostic criteria of PSP formulated by Parkinson's Disease and Dyskinesia Group of Chinese Medical Association Neurological Society in 2016 and the PSP clinical diagnostic criteria of International Society for Dyskinesia (MDS) in 2017.
The above diagnosis needs to be made by experienced neurologists and confirmed by two doctors.
(5) Aged 18 to 80 years;
(6) At least one year after the course of the disease was determined, and the life expectancy was greater than or equal to one year.
(7) In the past three months, no drugs that may affect the progress of the disease, such as Rashaquilane and other confirmed drugs with disease modification, vitamin E, coenzyme Q10 and other drugs that may affect the progress of the disease, should be stopped for more than two weeks if the above drugs have been used;
(8) No long-term history of taking coffee or smoking. If so, the above food should be stopped for more than 2 weeks for elution.
(9) The patient has the ability to answer or cooperate with a series of scales or questionnaires involved in the study; he or her guardian can and will sign the informed consent.
Exclusion criteria: (1) Secondary Parkinson's syndrome caused by toxins, drugs, metabolism, ischemic-hypoxic encephalopathy, etc.
(2) Those who suffered from severe brain injury or complicated craniotomy within 5 years before admission;
(3) Patients with severe systemic diseases (cardiopulmonary diseases), consciousness disorders, stroke, severe coronary heart disease, diabetes mellitus, liver and kidney diseases, severe visual and hearing impairment, etc., affect their life expectancy;
(4) Complicated with intestinal diseases and mitochondrial diseases;
(5) Those who had a history of intracranial hemorrhage in the past three months and could not use butylphthalide drugs;
(6) Complicated with other serious diseases leading to cognitive impairment or with severe mental impairment;
(7) Anaphylaxis or intolerance to butylphthalide (Enpipr) at present or in the past;
(8) Researchers believe that visits and assistant examiners cannot be completed in accordance with the requirements of the research program.

Age minimum: 18
Age maximum: 80
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)

Intervention(s)

PD-Placebo:Placebo;PD-Butylphthalide:Butylphthalide;VP-Placebo:Placebo;VP-Butylphthalide:Butylphthalide;MSA-Placebo:Placebo;MSA-Butylphthalide :Butylphthalide ;PSP-Placebo:Placebo;PSP-Butylphthalide:Butylphthalide;

Primary Outcome(s)

the mean change of UPDRS score from baseline to 48 weeks(PD,VP);the mean change of UPDRS score from baseline to 48 weeks(MSA);the mean change of UPDRS score from baseline to 48 weeks(PSP);

Secondary Outcome(s)

PDQ-39;CGI;mNSS;MMSE;MoCA;Schwab England;SCOPA-COG;H&Y??;ESS;HAMD;HAMA;ADL;ROME III;

Source(s) of Monetary Support

Platform Construction Project of Southern Medical University, No. 02020318005

Ethics review

Status: Not approved
Approval date:
Contact: