EUCTR2017-004253-16-AT进行中（未招募）1 期
abilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy
Medizinische Universität Innsbruck, Universitätsklinik für Neurologie0 个研究点目标入组 48 人开始时间: 2018年2月27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.In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
- •2.For patients that completed NMS-Nab Study over 2 months prior to the Screening Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
- •3.Only patients without a drug-related SAE or moderate or severe AE during the NMS-Nab Study can be included in the study
- •4.Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
- •5.Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
- •6.The patient is in good health as determined by medical examination.
- •The inclusion criteria of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal trial were as follows:
- •1.age =30 years
- •2.diagnosis of PD (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.Signed a current IRB-approved informed consent form
- •7.Acceptable method of contraception
- •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.Patients that experienced a drug-related SAE or had a moderate or severe AE during the NMS-Nab Study will be excluded in the study.
- •The exclusion criteria of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal trial were as follows:
- •1.Previous participation in any study with nabilone
- •2.current use of cannabinoids or use within 30 days prior to screening
- •3.current or recent (within 30 days prior to screening) participation in another study with an investigational medicinal product
- •4.atypical or secondary parkinsonism
- •5.presence of motor complications if, 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 ON > 3
- •7.Evidence of disturbing impulse control disorder
- •8.History of neurosurgical intervention for PD
- •9.Presence of clinically significant symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
- •10.Use of prohibited medication listed in 7.4.2
- •11.Laboratory values clinically significant out-of-range at screening or within 4 weeks prior to screening
- •12.Known or 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.recent suicidal attempt within the past five years or suicidal ideation within the past 6 months
- •15.presence of dementia (MDS-UPDRS 1.1 > 2, MMSE of < 24 at screening)
- •16.clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation (based on the investigator’s judgment).
- •17.moderate or severe hepatic or renal impairment.
- •18.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 [*Acceptable methods of birth control for women and men in this study are: surgical sterilization (e.g. tubal ligation for females), intrauterine devices that release hormones (hormone spiral), oral hormonal contraceptive, contraceptive patch, dermal hormonal contraception, vaginal hormonal contraception (NuvaRing®), implants that release progesterone (Implanon®), long-acting injectable contraceptive, partner’s vasectomy, a double-protection method, postmenopausal (> 2 year absence of vaginal bleeding).]
- •20.Pregnant women, or women planning to become pregnant during the course of the study, or nursing women.
- •21.Known hypersensitivity to any components of the IMP or excipients
- •22.Patient is legally incapacitated 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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