JPRN-jRCT2080220857未知3 期
A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa
试验速览
- 阶段
- 3 期
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1. Patients diagnosed as having PD in accordance with the Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)
- •2. Patients aged >30 years and <80 years at the time of informed consent
- •3. Patients with a modified Hoehn & Yahr scale score of 2 to 4 (on time)
- •4. Patients with a UPDRS Part III total score of >10 at screening (on time)
- •5. Patients who have received a fixed dose of L-dopa (ie, no change in daily dose or dosing regimen) for at least 28 days prior to the baseline (including a day for initial treatment)
- •6. Patients with any of the following problematic symptoms :
- •a. Wearing off phenomena (including frozen gait at off time and dystonia at off time)
- •b. On-off phenomenon
- •c. Delayed on and/or no-on phenomena
- •d. Dyskinesia
- •e. Insufficient efficacy of L-dopa
排除标准
- •1. Patients who have participated in a study of SPM 962 and received administration of study drug
- •2. Patients with psychiatric symptoms, eg, confusion, hallucination, delusion, excitation, delirium, or abnormal behavior at screening or baseline
- •3. Patients who show a decrease of SBP from spine to standing position > 30 mmHg at screening or have orthostatic hypotension at baseline
- •4. Patients have a history of epilepsy, convulsion or the like
- •5. Patients with a complication or history of serious cardiac disorder or arrhythmia (eg, NYHA Class III or IV congestive heart failure, second- or third-degree AV block, complete left bundle branch block, sick-sinus-syndrome, history or complication of ventricular fibrillation, myocardial infarction within 12 months prior to screening or complication of angina pectoris)
- •6. Patients demonstrating QTc interval of >450 msec twice at screening Patients whose average QTc interval for two baseline measurement is >470 msec (females) or>450 msec (males)
- •7. Patients with congenital long QT syndrome
- •8. Patients with serum potassium <3.5 mEq/L at screening
- •9. Patients have a total bilirubin >3.0 mg/dL or AST(GOT) and/or ALT(GPT) 2.5 times greater than the upper limit of the reference range (or >100 IU/L) during screening, or patients suffer complications of active phase of chronic hepatitis or liver cirrhosis
- •10. Patients with BUN >30 mg/dL or serum creatinine >2.0 mg/dL at screening
- •11. Patients with a history of allergy to topical medicine such as transdermal patches
- •12. Patients have a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent patients from receiving treatment
- •13. Female patients who are pregnant or nursing or who plan on becoming pregnant during the study period
- •14. Patients undergoing therapy with a drug prohibited by the specifications in Section 6.6.1, Prohibited Concomitant Therapy, in the study protocol
- •15. Patients with a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant
- •16. Patients suffering dementia, including DLB and PDD (MMSE score :24 at screening)
- •17. Patients with a history or the complications of a malignant neoplastic disease within 12 months prior to screening or have been treated for the disease
- •18. Patients incapable of giving consent
- •19. Patients incapable of keeping an appropriate patient diary
- •20. Patients are participating in another study of an investigational drug or have received another investigational drug within the last 12 weeks prior to the baseline
- •21. Patients otherwise judged by the investigator or sub-investigator to be ineligible for the study
研究者
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