EUCTR2018-004145-16-IT进行中（未招募）1 期
A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy. - Safinamide for Multiple System Atrophy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ZAMBON SPA
- 入组人数
- 48
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Participant must be 30 to 80 years of age inclusive, at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2. Participants who are diagnosed (with MRI confirmation) with possible or probable parkinsonian variant of Multiple System Atrophy
- •less than 2 years ago.
- •3. Participants with an anticipated survival of at least 3 years in the opinion of the investigator.
- •4. Male or female
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies (see Appendix 4):
- •i. Not a woman of childbearing potential (WOCBP)
- •ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention.
- •Informed Consent
- •5. Capable of giving signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. History of neurosurgical procedure, including stereotactic surgery.
- •2. History of Deep Brain Stimulation (DBS)
- •3. History of bipolar disorder, severe depression, schizophrenia or other psychotic disorder.
- •4. History of drug and/or alcohol abuse within 12 months prior to screening as defined by the current edition of the Diagnostic and
- •Statistical Manual of Mental Disorders
- •5. History of dementia (DSM-V criteria)
- •6. Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
- •7. Active hepatitis B or C
- •8. History of human immunodeficiency virus (HIV) infection
- •9. Subjects not able to swallow oral medications
- •10. Subjects with severe orthostatic symptoms
- •11. Impaired ambulation, i.e. falling more than once per week, bedridden patients or confined to a wheelchair during the whole day.
- •12. Subjects with active malignant neoplasms.
- •13. Movement disorders other than MSA (e.g. Parkinson Disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, pharmacological or post-encephalic parkinsonism).
- •14. Any clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion
- •of the study or might affect the results of the study.
- •Prior/Concomitant Therapy
- •15. Not on a stable regime, for at least 4 weeks prior to the randomization (baseline visit), of
- •a. oral levodopa (including controlled release [CR], immediate release [IR] or a combination of CR/IR), with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor
- •b. dopamine agonist, anticholinergic and/or amantadine.
- •Prior/Concurrent Clinical Study Experience
- •16. Patients should not have received treatment with monoamine oxidase inhibitors in the 2 weeks prior to the randomization visit, nor treatment with levodopa infusion, pethidine, opiates, opioids, fluoxetine, fluvoxamine in the 4 weeks prior to the randomization visit.
- •17. Patients should not have received treatment with an oral or depot neuroleptic within 12 weeks prior to the randomization visit.
- •18. Use of any investigational drug within 30 days prior to screening or 5 half-lives, whichever is the longest.
- •Diagnostic assessments
- •19. Montreal Cognitive Assessment (MoCA) = 20
- •20. Laboratory assessments showing moderate or severe hepatic impairment (2x ULN)
- •Other Exclusions
- •21. Allergy/sensitivity or contraindications to the investigational
研究者
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