EUCTR2017-000192-86-AT进行中（未招募）1 期
abilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study
Medizinische Universität Innsbruck, Universitätsklinik für Neurologie0 个研究点目标入组 48 人开始时间: 2017年8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
- 48
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.Age =30 years
- •2.Diagnosis of PD: PD should be either de novo or on stable medication without disturbing motor fluctuations or dyskinesia.
- •3.NMS with a score of =4 on MDS-UPDRS Part 1. One of the following domains have to be affected with a score =2: 1.4 (anxious mood) or 1.9 (pain)
- •4.On a stable regimen of anti-parkinson medications for at least 30 days prior to screening and willing to continue the same doses and regimens during study participation
- •5.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 subject must be willing to continue the same doses and regimens during study participation
- •6.Patient is informed and had enough time and opportunity to think about his/her participation in the study and has signed a current IRB-approved informed consent form
- •7.Contraception
- •a.Women of childbearing potential must use or attest an acceptable method* of contraception starting 4 weeks prior to study drug administration and for a minimum of 1 month after study completion.
- •b.Men with a potentially fertile partner must be willing to use an acceptable method* of contraception for the duration of the study and for 3 months after study drug discontinuation or have had a vasectomy.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1.Patient previously participated in any study with nabilone.
- •2.Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.
- •3.Patient is currently participating in or has participated in another study of investigational products within 30 days prior to screening.
- •4.Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
- •5.Patient presents with motor complications which are, based on the investigator’s judgment, not adequately controlled (i.e. a score =2 on one of the items of the MDS-UPDRS Part IV at screening)
- •6.Hoehn and Yahr stage > 3
- •7.Evidence of disturbing (i.e. requiring treatment) impulse control disorder in the participant. Can be resolved through a structural interview during screening period.
- •8.History of neurosurgical intervention for PD
- •9.presence of symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
- •10.Use of prohibited medication listed in 7.4.2
- •11.Patients with laboratory values that are out-of-range at Screening or within 4 weeks prior to screening and haven´t been reviewed and documented as not clinically significant by the investigator. Lab Tests can be repeated for confirmation.
- •12.Patients with known or newly diagnosed sinus tachycardia in ECG Evaluation at screening or within 4 weeks prior to screening.
- •13.presence of an acute or chronic major psychiatric disorder (e.g., Major Depressive Disorder, psychosis) or symptom (e.g., hallucinations, agitation, paranoia) (MDS-UPDRS 1.2 and/or 1.3 > 2)
- •14.Patients who had a recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months.
- •15.presence of dementia (MDS-UPDRS 1.1 > 2, MMSE of <24 at the Screening visit)
- •16.clinically significant or unstable medical or surgical condition at Screening or Baseline visit that may preclude safety and the completion of the study participation (based on the investigator’s judgment).
- •17.Patients with moderate or severe hepatic or renal impairment.
- •18.Patient has a history of chronic alcohol or drug abuse within the last 2 years.
- •19.women of child-bearing potential who do not practice an acceptable method of birth control (See: acceptable methods of birth control at 4.1.)
- •20.Pregnant women or women planning to become pregnant during the course of the study and nursing women.
- •21.Patients who are knowingly hypersensitive to any of the components of the IMP or excipients.
- •22.Patient is legally incapacitated (for example: patient ist incapable of giving consent personally) or persons held in an institution by legal or official order
- •23.Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
研究者
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