EUCTR2017-003458-18-SE进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia
Integrative Research Laboratories AB (IRLAB)0 个研究点目标入组 74 人开始时间: 2018年12月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
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
入选标准
- •1.Male or female =18 and =79 years of age.
- •2.Signed a current Ethics Committee approved informed consent form.
- •3.Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- •4.Waking day dyskinesia of =25% determined as a score of =2 as per Question 4.1 of the MDS-UPDRS.
- •5. On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.
- •6.Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.
- •7.Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis).
- •8.Patients must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
- •9. Able to complete at least one valid 24-hour patient diary at Visit 1.
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •1.History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation).
- •2.Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).
- •3.History of seizures within two years prior to screening.
- •4.History of stroke or transient ischemic attack (TIA) within two years prior to screening.
- •5.History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- •6.Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening.
- •7.A Hoehn and Yahr stage of five.
- •8. Any history of a significant heart condition, or cardiac arrhythmias within the past 5 years, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
- •9. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; clinically significant symptomatic orthostatic hypotension; clinically significant hepatic disease;, renal failure, or a abnormal renal function.
- •10. Any history of a neurological or other than Parkinson’s disease or a psychiatric disorder, including history of DSM IV diagnosed major depression, or psychosis. Patients with illusions or hallucinations with no loss of insight will be eligible Patients with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.
- •11. Enrolment in any other clinical study involving medication, medical devices or surgical procedures, current or within three months prior to screening visit, or previous participation in the present study. Patients enrolled in non-interventional clinical trials will be eligible.
- •12.Drug and/or alcohol abuse
- •13.History of severe drug allergy or hypersensitivity
- •14.If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose
- •15.Patients unwilling to use two forms of contraception (one of which being a barrier method see Section 7.3) 90 days for men and 30 days for women after last IMP dose
- •16.Any planned major surgery within the duration of the study
- •17.Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement
研究者
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