EUCTR2004-000833-12-ES进行中（未招募）1 期
A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.
ewron Pharmaceuticals S.p.A.0 个研究点目标入组 0 人开始时间: 2004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
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. Male or female, age 30-80 years, inclusive. If female, they must be either post-menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients older than 80 years, who meet all other entry criteria, will be considered for enrollment, with approval of the Newron Medical Expert.
- •2. Diagnosis of idiopathic Parkinson’s disease of less than 5 years duration, with Hoehn and Yahr stage I-III.
- •3. Patients must have been receiving treatment with a single dopamine agonist at a stable dose for at least 4weeks prior to the screening visit. Patients will receive the study medication as add-on therapy starting at baseline.
- •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
- •· The patient has any indication of forms of parkinsonism other than idiopathic Parkinson’s Disease.
- •· The patient is currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
- •· The patient has a concomitant disease likely to interfere with the study
- •· The patient has hypersensitivity or contraindications to MAO-B inhibitors.
- •· The patient has participated in a previous clinical trial within 30 days of entry into the study (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •· The patient has received treatment of his/her parkinsonian symptoms with a medication, other than a single dopamine agonist, during the 4 weeks preceding the screening visit.
- •· The patient has received treatment with opioids, SNRIs, tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), meperidine derivatives, oral neuroleptics or any agent known to significantly inhibit or induce drug-metabolizing enzymes within 4 weeks prior to the screening visit.
- •· The patient has received a depot neuroleptic within one injection cycle.
- •· The patient has received treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
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