EUCTR2015-001786-10-GB进行中（未招募）1 期
A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)0 个研究点目标入组 40 人开始时间: 2015年11月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Hoehn and Yahr stage = 3.0
- •2. Ambulatory with or without assistance
- •3. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., hormonal methods, including oral, subcutaneous, and intrauterine; barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.
- •4. Willingness and ability to comply with study procedures
- •5. If on medications and supplements for Parkinson's disease, then regimen must be stable for 60 days prior to enrollment
- •6. Abstention from use of other investigative or non-approved drugs for the duration of the trial
- •7. For idiopathic subjects: a diagnosis of idiopathic Parkinson's disease confirmed by the presence of bradykinesia plus one or both of the following symptoms: rigidity or resting tremor; and with an abnormal DaTscan consistent with a dopaminergic deficit
- •8. For idiopathic subjects: age 40 to 75 years
- •9. For idiopathic subjects: within 5 years of diagnosis of Parkinson’s disease
- •10. For genetic subtype subjects: a confirmed diagnosis of Parkinson's disease plus a genetic diagnosis consistent with Parkinson's disease, specifically PINK1, parkin, LRRK2 or other mitochondrial genetic subtype
- •11. For genetic subtype subjects: age 21 to 75 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Allergy to EPI-589 or other components of the EPI-589 tablet formulation
- •2. Vitamins E and C beyond the recommended daily allowance.
- •3. Other Parkinsonian disorders
- •4. MoCA score of < 24
- •5. Revised Hamilton Rating Scale for Depression = 11
- •6. Parkinsonism due to drugs or toxins
- •7. Diagnosis of any other clinically significant neurologic disease that will confound the assessment of effect of study drug on disease progression
- •8. Malignancy within past two years
- •9. Pregnant or plans to become pregnant or breast feeding
- •10. History of stroke
- •11. History of brain surgery
- •12. Hepatic insufficiency with liver function tests (LFTs) > 3 times upper limit of normal
- •13. Renal insufficiency as defined by creatinine > 1.5 times normal
- •14. End stage cardiac failure
- •15. Participation within past 3 months and for duration of study in a trial of a device, drug or other therapy for Parkinson's disease
研究者
相似试验
进行中（未招募）
1 期
A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.Parkinson’s diseaseMedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disordersEUCTR2015-001786-10-DEBioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)40
招募中
1 期
Clinical Pharmacology Study of EPI-589Amyotrophic lateral sclerosisJPRN-jRCT2071210023Hamatani Tatsuto40
已完成
1 期
Clinical Pharmacology Study of EPI-589Amyotrophic lateral sclerosisJPRN-jRCT2071210022Hamatani Tatsuto68
已完成
2 期
EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALSJPRN-jRCT2061210031Fujita Koji10
招募中
2 期
A study to test an oral combination of letrozole and everolimus for patients with advanced lung cancer who have progressed on first line chemotherapy.on Small Cell lung cancerNon Small Cell lung cancerCancer - Lung - Non small cellACTRN12607000218493Dept of Medical Oncology, Royal Adelaide Hospital20