EUCTR2009-012419-16-DE进行中（未招募）不适用
Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD
相关药物
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
- •- Male or female Caucasian patients aged 35 to 80 years;
- •- Patients with idiopathic Parkinson's disease;
- •- Hoehn & Yahr stages 1 to 4;
- •- Stable medication with anti-parkinsonian medication, including stable treatment with pramipexole or ropinirole, for at least 4 weeks prior to Screening;
- •- Significant daytime sleepiness: Epworth Sleepiness Scale score ?equals or is greater than 11 under previous therapy with pramipexole or ropinirole;
- •- Patients who have read and understood the patient information sheet and have provided a signed written informed consent form;
- •- Patients are considered to be compliant to the study regimen.
- •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
- •- Treatment of Parkinson’s disease with any dopamine agonist other than pramipexole or ropinirole within 4 weeks prior to Screening;
- •- Known hypersensitivity to Clarium or its excipients;
- •- Patients with daytime sleepiness caused by other factor’s than Parkinson’s disease, i.e., idiopathic narcolepsy, shift work, severe alcohol abuse, obstructive diseases, sleep apnea syndrome, or Periodic limb movement disorder;
- •- Secondary and atypical Parkinson syndrome;
- •- Depression (Beck Depression Inventory ?score greater than 16);
- •- Dementia (Mini-Mental State Examination score equal to or smaller than 24);
- •- Severe disability in extremities which could influence clinical assessments;
- •- Clinically significant disease concerning the lung, liver or kidney;
- •- Any acute or chronic infection that may influence the outcome of the study;
- •- Cardiovascular shock;
- •- Acute myocardial infarction;
- •- Congestive heart failure NYHA class III or IV;
- •- Uncontrolled arterial hypertension (diastolic blood pressure equal to or greater than 105 mmHg) or clinically relevant hypotension;
- •- Evidence of clinically active cancer;
- •- Color vision defect that may have impact on assessment of FWIT;
- •- History of substance abuse;
- •- Intake of benzodiazepines (or derivates) if not at stable dose for at least 4 weeks prior to Screening; antiallergic agents (H1 receptor antagonists, except selective, non-sedating H1-antihistamines, e.g. loratadine and others), substances with psychostimulant properties (e.g., amphetamine, modafinil), or antidepressants if not at stable dose for at least 2 months prior to Screening;
- •- Current treatment with neuroleptic agents (except for clozapine);
- •- Female patients who are pregnant or lactating;
- •- Female patients of childbearing potential who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner;
- •- Mental condition rendering the patient unable to understand the nature, scope and possible risks of the study;
- •- Patient has a history of or is suspicious of unreliability, poor co-operation or non-compliance with medical treatment;
- •- Patients are currently or previously (within the last 28 days) participating in another study of an investigational drug;
- •- Patients who were previously enrolled in this study;
- •- Patients with known Hepatitis B or C or HIV infection;
- •- Patients who are employees of the sponsor or patients who are employees or relatives of the investigator.
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