EUCTR2007-003134-42-DE进行中（未招募）不适用
A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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 patients aged 45 to 75 years (inclusive).
- •2. Patients with an MMSE score of at least 25 at the screening visit.
- •3. Patients who experience EODWO, defined as re-emergence of PD symptoms during the waking hours, as determined by a WOQ-9 score of at least one motor symptom of wearing off. An item is considered positive when it is present and when the referring symptomatology improves with the next dose of dopaminergic medication.
- •4. Patients taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks prior to randomization, at an equivalent total daily dose of levodopa between 300 to 600 mg/day.
- •5. Patients who, in the investigator’s judgement, are capable of satisfying the
- •requirements of the protocol.
- •6. Patients who are willing and able to give written informed consent according to legal requirements.
- •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. Diagnosis of secondary parkinsonism, atypical Parkinson’s disease, or history, signs, or symptoms suggesting these diagnoses.
- •2. Unstable Parkinson’s disease as determined by the investigator.
- •3. Disabling dyskinesia (a score of >2 on the Unified Parkinson’s Disease Rating Scale
- •[UPDRS] question #32, or a score of >2 on UPDRS question #33).
- •4. Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release Sinemet is not allowed on the evening before the visits in which efficacy assessments occur.
- •5. Treatment with <3 or >4 daily doses of immediate release carbidopa/levodopa of any dose form within 4 weeks (28 days) prior to randomization (this allows combination of different strengths).
- •6. Patients requiring less than three levodopa/carbidopa doses per day
- •7. Patients who are unable to comply with the dosing requirements of the protocol, such that the first dose of study medication will be taken after the time of the first EEG and the second dose will be taken after completion of the third EEG.
- •8. Treatment with monoamine oxidase type A (MAO-A) inhibitors or neuroleptics,
- •within 60 days prior to the randomization.
- •9. Treatment with selegiline or rasagiline within 4 weeks (28 days) prior to
- •randomization.
- •10. Concomitant treatment with dopamine agonists or catechol O-methyltransferase
- •(COMT) inhibitors within 4 weeks ( 28 days) of randomization), or at any time in the
- •past if, in the perspective of a treating physician, the patient experienced serious or
- •severe adverse event(s) or treatment failure that resulted in the discontinuation of
- •11. Current treatment with anticoagulants. Aspirin taken for health or cardiac prophylaxis will be permitted, provided that the total daily dose does not exceed 81 mg.
- •12. Treatment with a benzodiazepine or any sleep medication. As needed use of these medications will be permitted; however, they may not be administered during the 48 hours prior to the Week 6 or Week 12 visits.
- •13. Use of magnesium supplements within 4 weeks (28 days) prior to randomization.
- •14. Treatment with angiotensin-converting enzyme (ACE)-inhibitors within 28 days prior to randomization.
- •15. Treatment with oral or inhaled glucocorticoids (topical preparations are permitted) within 3 months prior to randomization.
- •Please refer to the enclosed protocol for a detailed description of all exclusion criterias.
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