Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease

• Register: ChiCTR
• Last refreshed on: 9 July 2018
• Main ID: ChiCTR1800016949
• Date of registration: 2018-07-04
• Prospective Registration: Yes
• Primary sponsor: Beijing Hospital
• Public title: Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease
• Scientific title: Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease
• Date of first enrolment: 2018-08-01
• Target sample size: Rasagiline early start group:130;Rasagiline delay start group:130;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=28754
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Wen Su
• Affiliation: Beijing Hospital

• Name: Haibo Chen
• Affiliation: Beijing Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Chinese man or woman aged 30 to 80 years old;
2. A patient with idiopathic Parkinsons disease (PD) whose diagnosis is confirmed by 2015 MDS diagnostic criteria;
3. The patient has a Modified Hoehn and Yahr stage < 3 (1-2.5);
4. Total MMSE score =24;
5. The patient is not taking any anti-parkinsonian medication prior to baseline or has discontinued more than 4 weeks;
6. The patient must be willing and able to give informed consent.
Exclusion criteria: 1. Drugs (such as metoclopramide, flunarizine), metabolic diseases (such as Wilson disease), encephalitis and central nervous system degenerative diseases (such as youth Huntington disease, progressive paranuclear palsy, multiple system atrophy) or basal ganglia disease (such as Fahr's disease or syndrome, etc.) related Parkinsonism or Parkinson plus syndrome (CT or MRI confirmed that the basal ganglia area has a clear lesion within 2 years);
2. Patient who can not sign informed consent or with cognitive dysfunction that affect the patient's medication compliance. (Note: For suspicious cases, ONLY patients who are not dementia and confirmed by physicians not related to this study can provide informed consent, exclude patients with MMSE = 24);
3. Patient with a history of mental illness;
4. Patient with a history of active epilepsy (ie seizures) within the first two years prior to enrollment;
5. Patient with II or III degree atrioventricular block or sick sinus syndrome;
6. Patient with resting heart rate less than 50 times / minute;
7. Patient with congestive heart failure classified as Class III or IV according to the Heart Function of the New York Heart Association;
8. Patient with myocardial infarction within six months prior to enrollment;
9. Other heart diseases (such as coronary artery disease) that have clinical significance and can affect the patient's completion of the trial;
10. Clinically significant kidney disease that may prevent the patient from completing the trial, and/or serum creatinine above the normal range of the laboratory, and/or blood urea nitrogen is 1.5 times above the normal range;
11. Clinically significant liver disease may prevent the patient from completing the test, and/or total bilirubin, aspartate aminotransferase, or alanine aminotransferase is higher than the normal laboratory value, ie, more than 1.2 times the normal value, still higher than normal value after reviewed;
12. Patient with pigmented retinopathy;
13. Patient who suffer from cancer, or with a history or family history of cancer;
14. Patient with a history of surgery within 180 days prior to enrollment, or with a history of stereotactic brain surgery or with a history of treatment that may affect clinical trial assessed by investigator;
15. The systolic blood pressure in the selected position is less than 100mmHg, or the systolic blood pressure in standing position reduced by 20mmHg compared with lying position, and the decrease in blood pressure is related to the symptoms (ie, symptomatic postural hypotension);
16. Patient who take any of the following medications within 30 days prior to baseline, and these medications are prohibited during the study period:
(1) Aggravating diseases: methyldopa, flunarizine, cerebralazine;
(2) May cause hypertension: Ritalin hydrochloride, amphetamine derivatives, sympathomimetic amines;
(3) Orthostatic hypotension may be aggravated: ß-blockers (such as propranolol), reserpine;
(4) CYP1A2 inhibitors: cimetidine, ciprofloxacin, levofloxacin, norfloxacin, fluvoxamine, paroxetine, isoniazid, clarithromycin, erythromycin ethylsuccinate, estrogen, ketone Conazole, Gemfibrozil, Propafenone, Mexiletine;
(5) CYP1A2 Inducer: Omeprazole;
(6) MAO metabolism related: 5-HT antidepressant (fluoxetine, venlafaxine, sertraline, citalopram);
(7) Aggravating central inhibition: analgesic anesthetics such as meperidine, tramadol, methadone;
(8) Induced mental symptoms: dextromethorphan;
(9) Others: p

Age minimum: 30
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's disease

Intervention(s)

Rasagiline early start group:rasagiline-rasagiline;Rasagiline delay start group:placebo-rasagiline;

Primary Outcome(s)

UPDRS I-III;

Secondary Outcome(s)

CGI;PDQ-39;PFS-16;

Source(s) of Monetary Support

Ministry of Science and Technology, China

Ethics review

Status: Approved
Approval date:
Contact:

Wei Liu