JPRN-jRCTs051200160已完成2 期
Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease: A Randomized Single-Blind Placebo-Controlled Trial - ZEA
Hiroshi Kataoka0 个研究点目标入组 70 人开始时间: 2021年3月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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
- >= 41age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients at age of 41 years or older at the time of informed consent
- •2. Patients with Parkinson's disease (The use of other antiparkinson's disease drugs in addition to the levodopa-containing drugs did not work effectively)
- •3. Patients diagnosed with Parkinson's disease based on the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria (The preganglionic dopaminergic decline in functional images does not matter)
- •4. Patients who have been treated with levodopa and a dopamine decarboxylase inhibitor for at least a consecutive month and responded to anti-Parkinson's drug
- •5. Patients with the regimen of levodopa and other anti-Parkinson's drug did not change from 2 weeks prior to participation into this study to the time of informed consent.
- •6. Patients with stages 1 to 4 in the Hoehn & Yahr severity classification
- •7. 22 points or more on the Mini-Mental State Examination (MMSE)
- •8. In Parkinson's disease sleep scale-2: PDSS-2 Japanese version item 1 those scored Did you sleep well last week? Sometimes (2-3 times a week) Almost none (once a week) Nothing or those who scored Did you have a bad day at night? Sometimes (2-3 times a week) Many (4-5 times a week) So much (6-7 times a week) in PDSS-2 Japanese version item 2 or those who scored 5 or more in the Japanese version of the REM sleep behavior disorder (RBD) screening questionnaire.
- •9. Patients who have given written consent from the patient or his / her substitute for participation in this study
- •10. Outpatient
排除标准
- •1. Patients who have been treated with Zonisamide within 3 months prior to obtaining informed consent
- •2. Patients with a history of brain surgery including deep brain stimulation surgery
- •3. Patients with a history of other organic cerebral disorders such as stroke and epilepsy
- •4. Patients with serious renal dysfunction (eGFR is 30 and less) or hepatic disfunction within 6 months prior to patient's consent
- •5. Patients with a history of malignant syndrome
- •6. Patients with a history of suicide attempts
- •7. Patients taking antiepileptic drugs
- •8. Patients taking both MAO-B inhibitors and tricyclic antidepressants
- •9. Patients with severe dyskinesia
- •10. Patients with severe mental disease
- •11. Women with potential and intention to become pregnant
- •12. Patients who meet any of the following
- •Patients with a history of toxic epidermal necrolysis (TEN)
- •mucocutaneous ocular syndrome (Stevens-Johnson syndrome), and erythroderma (exfoliative dermatitis)
- •13. Patients with a history of hypersensitivity syndrome within 5 years prior to obtaining informed consent
- •14. Patients with a history of interstitial pneumonia within 5 years prior to obtaining informed consent
- •15. Patients with a history of rhabdomyolysis within 5 years prior to obtaining informed consent
- •16. Patients with aplastic anemia, agranulocytosis, pure red cell aplasia, thrombocytopenia
- •17. Patients using a pacemaker
- •18. Patients with a history of hypersensitivity to the components of Zonisamide
- •19. Patients participating in other clinical trials
- •20. Other patients who the principal investigator (sharing) judges to be inappropriate
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