EUCTR2007-003353-90-FR进行中（未招募）1 期
A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
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 patient with idiopathic Parkinson’s disease (PD) confirmed
- •by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •2.Parkinson’s disease diagnosed within 5 years.
- •3.Patients 30 years of age or older at the time of diagnosis.
- •4.Modified Hoehn and Yahr stage of 1 to 3.
- •5.Patients receiving pramipexole IR at least three months prior to baseline
- •visit (randomization visit, V2)
- •6. Pramipexole dose should optimized according to the investigator’s
- •judgement, greater or equal to 1.5 per day, stable and equally divided
- •times a day, for at least 4 weeks prior to baseline visit (V2)
- •7.Patients willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests and other study procedures.
- •8.Signed informed consent obtained before any study procedures are
- •carried out (in accordance with ICH-GCP guidelines and local legislation).
- •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
- •Medical exclusions:
- •1.Motor complications under levodopa therapy (e.g. on-off phenomena,
- •dyskinesia) at screening visit
- •2.Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide,
- •flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or
- •degenerative diseases (e.g., progressive supranuclear palsy).
- •3.Dementia, as defined by a Mini-Mental State Exam score < 24 at screening
- •4.Any psychiatric disorder according to DSM-IV (Diagnostic and Statistical
- •Manual of Mental Disorders, 4th edition) criteria that could prevent
- •compliance or completion of the study and/or put the patient at risk if
- •he/she takes part in the study.
- •5.History of psychosis, except history of drug induced hallucinations
- •(provided the investigator considers that participation in the trial would
- •not represent a significant risk for the patient).
- •6.Clinically significant electrocardiogram (ECG) abnormalities at screening
- •visit, according to investigator’s judgement.
- •7.Clinically significant hypotension (i.e. supine systolic blood pressure < 90
- •mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms
- •of orthostatic hypotension associated with a decline = 20 mmHg in
- •systolic blood pressure and a decline = 10 mmHg in diastolic blood
- •pressure, at one minute after standing compared with the previous
- •supine systolic and diastolic blood pressure obtained after 5 minutes of
- •quiet rest) either at screening visit or at baseline visit.
- •8.Malignant melanoma or history of previously treated malignant melanoma.
- •9.Any other clinically significant disease, whether treated or not, that could
- •put the patient at risk or could prevent compliance or completion of the
- •10.Pregnancy (to be excluded by urinary pregnancy test at screening visit) or
- •breast-feeding.
- •11.Sexually active female of childbearing potential (less than 24 months post-menopausal and not surgically sterilised, hysterectomised or bilaterally ovariectomised, or their partner not vasectomised) not using a highly effective method of birth control, i. e. hormonal forms of contraception (such as combined oral contraceptives, hormonal intrauterine devices, implants, injectables) for at least one month prior to the screening visit and throughout the study period (up to the follow-up visit).
- •12.Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin
- •> 2 ULN (on screening lab test).
- •13.Patients with a creatinine clearance < 50 mL/min (estimated by the
- •Cockcroft and Gault formula and calculated by the local lab or by the
- •investigator on screening lab test)
- •Pharmacological exclusions:
- •14.Any dopamine agonist (except pramipexole IR) within three months prior
- •to baseline visit.
- •The following concomitant PD treatments are allowed, provided they are at a stable dose for at least 4 weeks prior to baseline and the investigator does not intend to change this treatment during the treatment phase: L-Dopa+, and/or anti-Parkinsonian anticholinergics, and/or selegiline, rasagiline, or other MAO-B Inhibitors, and/or amantadine, and/or entacapone (or other COMT-Inhibitors), and/or beta-blocke
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