EUCTR2005-006033-32-FI进行中（未招募）不适用
A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •-The clinical diagnosis of subjects must meet the criteria for Diagnosis of idiopathic Parkinson’s Disease according to the modified UKPDS Brain Bank criteria (see Appendix ?16.3)
- •-Modified Hoehn and Yahr up to stage 3
- •-Unified Parkinson’s Disease Rating Scale (UPDRS) motor score (part 3) must have a total of at least 10 at baseline
- •-Out patients
- •-Subjects of more than 30 years old
- •-For anti-PD medication other than SLV308, the following criteria apply:
- •-subjects may have had treatment with L-dopa formulations or dopamine agonists up to a total of 90 days.
- •-subjects must have stopped the use of L-dopa and/or dopamine agonists for at least 90 days prior to baseline.
- •-efficacious previous treatment is not allowed to be stopped for the sole purpose of enrolling the subject into this study
- •-concurrent anti-PD treatment other than L-dopa and dopamine agonists (i.e. selegiline, rasagiline, anti-cholinergics, amantadine) is allowed if the doses have been kept stable for at least 28 days prior to baseline and will be kept stable during the study.
- •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
- •Related to Parkinson’s disease
- •- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g. multiple system atrophy, progressive supranuclear palsy) or heredodegenerative diseases.
- •- Subjects who have undergone surgery for the treatment of PD (e.g. pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery.
- •- Presence of dyskinesias, motor fluctuations or loss of postural reflexes.
- •- Subjects with a history of non-response (according to both the clinician and the subject) to an adequate course of L-dopa or a dopamine agonist.
- •- Subjects for whom previous treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and/or sleep attacks.
- •- Treatment within 60 days prior to baseline with monoamine oxidase (MAO) inhibitors (other than selegiline and rasagiline), alpha methyldopa or metoclopramide; treatment within last 30 days before baseline with parenteral ergots, methylphenidate, amphetamine, beta-blockers for treating tremor, isoprenaline, adrenaline, dopamine, dobutamide, reserpine, flunarizine or cinnarizine.
- •- Exposure to any investigational drug within 60 days prior to Visit 1.
- •- Breast feeding or pregnant women.
- •- Prior exposure to SLV308.
- •- Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
- •- Any other reason that, in the investigator’s opinion, prohibits the inclusion of the subjects into the study.
研究者
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