EUCTR2008-002769-30-IT进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Gender: male or female
- •2. Age: ? 30 years
- •3. BMI: 18 - 32 kg/m2
- •4. Diagnosed with idiopathic Parkinson?s disease, with H&Y of I-III
- •5.Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa
- •6.ECG Normal
- •7.Negative beta-HCG test and not lactating (females).
- •8.Ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home
- •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. Co-administration of other drugs causing dopamine release or affecting levodopa metabolism
- •2. Co-administration of other MAO inhibitors
- •3. The patient is in a late stage of Parkinson?s disease
- •4. Any indication of forms of Parkinsonism, other than idiopathic Parkinson?s disease.
- •5.Treatment with any agent known to inhibit or induce drug-metabolizing enzymes within 4 weeks prior study treatment
- •6.Concomitant oral iron treatment
- •7.History of hypersensitivity or contraindications to MAO-B inhibitors or levodopa
- •8.Clinically relevant allergies 9.Significant hepatic impairment
- •10.Significant renal impairment
- •11.Diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility
- •12.Diagnosis of HIV, or acute Hepatitis B or C
- •13.Clinically relevant disease
- •14.A neoplastic disorder, which is either currently active or has been in remission for less than one year.
- •15. Active psychiatric disease
- •16. History of melanoma
- •17.Signs for dementia
- •18.Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity
研究者
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