EUCTR2010-022200-46-FI进行中（未招募）不适用
Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Written informed consent (IC) obtained.
- •Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose -motor fluctuations.
- •Hoehn and Yahr stage 2-4 performed during the ON state.
- •An average of ? 3.0 hours of OFF-time, with a minimum of 0.5 hours of OFF-time on each day (using PD home diary [hereafter diary] on 3 consecutive days before the decision of entry.
- •Treatment with 3-8 regular daily doses of levodopa/DDCI with entacapone (either levodopa/DDCI combined with Comtess®/Comtan® or as Stalevo®) or without entacapone, including daily use of soluble levodopa formulation, with a total daily levodopa dose in the range of 400-1400 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed providing that it is included in the total daily levodopa dose in the range of 400-1400 mg mentioned above. Use of additional soluble levodopa formulations as rescue treatment, such as Madopar LT or Quick, up to a maximum of 4 doses per week is allowed; however, its use should be avoided on days during which PD status (diary) is recorded. The
- •levodopa dose from these rescue soluble levodopa formulations is not included in the range of total regular daily dose of levodopa indicated above.
- •Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase [MAO] B inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 4 weeks prior to the screening visit.
- •Age of 30 years or above.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Secondary or atypical parkinsonism.
- •Current use of tolcapone (within 6 weeks prior to the first treatment period).
- •Previous tolerability problems with entacapone or tolcapone.
- •Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
- •Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also dopamine D2 receptor blocking antiemetics except domperidone). As an exception to the prohibition of use of antipsychotic drugs, 1 evening dose of an atypical antipsychotic is allowed.
- •Severe dyskinesias as judged by the investigator; however, mild to moderate dyskinesia not significantly affecting patient’s activities of daily living is allowed.
- •Currently active hallucinations.
- •Severe orthostatic hypotension as judged by the investigator.
- •Current dementia (Mini-Mental State Examination [MMSE] score < 24).
- •Problematic impulse control disorders (ICD) such as pathological gambling, hypersexuality or compulsive shopping within 6 months prior to the screening visit.
- •History of neuroleptic malignant syndrome (NMS) and/or non-traumatic (drug-induced) rhabdomyolysis
- •Past or current treatment with deep brain stimulation (DBS) or other surgical treatment for PD.
- •Narrow-angle glaucoma or pheochromocytoma.
- •Any active malignant cancer.
- •Patients with pre-planned elective surgery that is likely to change or impact on the control of PD symptoms, or involve hospitalisation.
- •Failure to demonstrate acceptable/appropriate use of the diary, despite adequate training, during the screening visit or other separate training sessions during the screening period.
研究者
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