EUCTR2007-003051-36-ES进行中（未招募）不适用
Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
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 of 40 years of age or older with a clinical diagnosis of idiopathic Parkinson’s disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
- •2. Female subjects must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a clinically acceptable method of contraception (such as intrauterine device [IUD], diaphragm, or oral, injectable [e.g. Depo-Provera] or implantable contraception [e.g. Norplant®
- •System]), for at least one month prior to randomization, during the study, and one month following completion of the study.
- •3. Subjects must have psychotic symptoms that developed after the diagnosis of Parkinson’s Disease was established. These symptoms must include visual hallucinations and/or auditory hallucinations and/or delusions.
- •4. Psychotic symptoms must have been present for at least one month and the subject must have actively experienced psychotic symptoms during the month prior to the Screening visit.
- •5. Symptoms severe enough to warrant treatment with an antipsychotic agent as documented by items A and B of the NPI, and defined as the sum of Hallucinations (Frequency × Severity) and Delusions (Frequency × Severity) = a total of 4.
- •6. Subject must be on stable dose of anti-Parkinson’s medication for 1 month prior to Study Day 1 (Baseline) and during the trial.
- •7. Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
- •8. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious.
- •9. The subject is willing and able to provide consent
- •10. Caregiver is willing and able to provide consent and agrees to accompany the subject to all visits.
- •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. Subject with psychotic symptoms (hallucinations and delusions) which could be better explained as a part of a toxic, metabolic or infection-induced delirium/encephalopathy, psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression.
- •2. Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson’s disease including, but not limited to, schizophrenia or bipolar disorder.
- •3. Subject has atypical parkinsonism (Parkinson’s plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism.
- •4. Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson’s disease.
- •5. Subject had dementia prior to or concomitantly with the diagnosis of Parkinson’s disease that may be inconsistent with a PD diagnosis.
- •6. A score on the Mini-Mental State Examination (MMSE) of <21
- •7. Subject has history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE.
- •8. Subject has visual impairment including visual acuity problems (e.g., cataracts) that may impair assessments or better explain visual hallucinations.
- •9. Subject is using or has used any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications).
- •10. Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the subject’s ability to participate in the study.
- •11. Subject has had a myocardial infarction in last six months
- •12. Subject has moderate to severe congestive heart failure (NYHA class III or IV)
- •13. Subject has known history or symptoms of long QT syndrome
- •14. Subject is on medications known to prolong the QT interval (as described in Appendix 1)
- •15. Subject has a screening and baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female.
- •16. Subject has clinically significant laboratory abnormalities that in the judgment of the investigator would jeopardize the safe conduct of the study
- •17. Subject is pregnant or breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Study Day 1 (Baseline) prior to randomization.
- •18. Subject has any surgery planned during the screening, treatment or follow-up periods.
- •19. Subject is likely to have an allergy or sensitivity to ACP-103 based on known allergies to drugs of the same class.
- •20. Subject has previously participated in any prior clinical study with ACP-103, and/or received of any other investigational drug within 30 days prior to the screening visit.
- •21. Subject is judged by the Investigator to be inappropriate for the study.
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