EUCTR2009-015928-28-SE进行中（未招募）不适用
A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •- Parkinson’s disease, defined according to the UK Brain Bank Criteria. Bradykinesia should be combined with one of resting tremor, rigidity or postural imbalance.
- •- Duration of L-dopa treatment of at least 3 years.
- •- Significant dyskinesias after L-dopa dosages according to clinical experience.
- •- Significant dyskinesias in a screening single dose L-dopa challenge using two
- •dyskinesia rating scales. The screening test is performed with a challenge dose of 150% of the normal regular dose of L-Dopa the patient is about to take at the time of testing. If no dyskinesias appear during the first challenge, the challenge may be repeated on an alternate day (and) significant dyskinesias in a patient self-administered diary with 3 levels with 3 grades (off, on without dyskinesias, on with hyperkinesias) after the challenge dose has been given. Patients can be included if one of the two challenge tests are positive and diary is positive for dyskinesias.
- •- Over 18 years of age.
- •- This inclusion criterion (2) applied to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) only. Must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study.
- •- Signed informed consent.
- •- Must be able to communicate effectively with the investigator and study coordinator.
- •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
- •- Exclusion criteria for Parkinson’s disease according to the UK Brain Bank Criteria for Parkinson’s disease.
- •- Fulfillment of any other atypical parkinsonism diagnosis according to published criteria for multiple system atrophy, progressive supranucelar paresis, dementia with Lewy body, corticobasal gangliotic disease and dementia with Parkinson’s disease.
- •- Any suspected secondary parkinsonism: drug induced parkinsonism; toxin-induced parkinsonism; trauma-induced parkinsonism; normal pressure hydrocephalus and vascular parkinsonism.
- •- Ongoing treatment with any anti-dopaminergic medications (neuroleptics) for the past 6 months.
- •- Ongoing treatment with any selective serotonin re-uptake inhibitors (SSRI) for the past 4 weeks.
- •- Ongoing treatment with any combined norepinephrine and serotonin re-uptake inhibitors (SNSRI) for the past 4 weeks.
- •- Significant depression defined as > 18 in the Montgomery Åsberg Depression Rating Scale combined with a clinical evaluation as to any clinical relevant depression.
- •- Pregnancy or breast-feeding.
- •- Reduced kidney function; defined as a creatinine level > 120 umol/L.
- •- Reduced liver function, defined as ASAT >1,0 ukat/L, or ALAT > 1,0 ukat/L, or GT > 1,6 ukat/L, or total bilirubin> 30 umol/L, eller ALP> 6,0 ukat/L.
- •- History of any other medical condition thought to interfere with the study or study medication (i.e., recent myocardial infarction, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure > 180 mmHg), ongoing severe infection).
- •- Receipt of an investigational drug within 30 days or 5 half-lives of the drug, whichever is longer, prior to entering this study.
研究者
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