EUCTR2007-002963-28-CZ进行中（未招募）不适用
A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist
ewron Pharmaceuticals SpA0 个研究点目标入组 839 人开始时间: 2007年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 839
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. Diagnosis of idiopathic Parkinson’s disease of less than 5 years duration, with a Hoehn and Yahr stage of I III. The diagnosis should be based on medical history and neurological examination.
- •2. Between the ages of 30 to 80 years, inclusive, at screening.
- •3. If female, be either post menopausal for at least 2 years, surgically sterilised or have undergone hysterectomy or, if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
- •4. Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.
- •5. Willing and able to participate in the trial and have provided written, 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any indication of forms of Parkinsonism, other than idiopathic Parkinson’s Disease.
- •2. If female, be pregnant or lactating.
- •3. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
- •4. Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
- •5. Current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. (Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion).
- •6. Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc = 450 msec (males) or = 470 msec (females), where QTc is based on Bazett’s correction method.
- •7. Have received treatment with safinamide previously.
- •8. Concomitant disease likely to interfere with the trial medication (e.g. capable of altering absorption, metabolism or elimination of the trial drug).
- •9. History of, or current psychosis (e.g. schizophrenia or psychotic depression), or with a score = 3 on item 2 (thought disorder) or 3 (depression) of the UPDRS Section I at screening.
- •10. Evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 24, or a score = 3 on item 1 (mentation) of the UPDRS, Section I at screening.
- •11. Depression, as indicated by a GRID HAMD (17 item scale) score > 17 at screening.
- •12. History of allergic response to anticonvulsants or anti-Parkinsonian agents.
- •13. Mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
- •14. Hypersensitivity or contraindications to MAO B inhibitors.
- •15. Current history of severe dizziness or fainting on standing, due to postural hypotension.
- •16. Neoplastic disorder, which is either currently active or has been in remission for less than one year.
- •17. Participation in a clinical trial within 30 days of entry into the trial (screening visit) or has received treatment with any investigational compound within 30 days or 5 half lives, whichever is longer, prior to screening.
- •18. Treatment of their Parkinsonian symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks preceding the screening visit.
- •19. Treatment with any agent known to significantly inhibit or induce drug-metabolizing enyzmes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.
- •20. Treatment with opioids (e.g., tramadol, meperidine derivatives), SNRIs (e.g., venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), in the 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough.
- •21. Treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit.
- •22. Treatment with a drug that has hepatotoxic potential, e.g., tamoxifen,
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