Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3
研究概览
简要总结
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease (PD). Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and therefore mimics the effect of THC but with more predictable side effects and less euphoria.
Eligible patients will be re-tapered in an open-label nabilone dose optimization phase followed by an open-label period of 6 months on a stable nabilone dose.
详细描述
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis.
Eligible subjects will be re-tapered with open-label nabilone, optimally up to the dose the patient had in the NMS-Nab Trial. It is the investigator´s decision to modify this dose, if necessary. The re-tapering will be performed up to a maximum dose of 1 mg twice daily. Treatment responders will enter the open-label treatment period for 6 months with visits being performed every 3 months in the context of the patient´s regularly scheduled visits in the specialized outpatient department. The last visit will be the Termination Visit. Following this, nabilone will be tapered. During this period the patients will receive phone calls every other day. A Safety Follow-Up Visit will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None, open-label
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for participation in the study, subjects must meet all inclusion criteria:
- •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.
- •For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
- •Only patients without a drug-related serious adverse event (SAE) or (drug-related) moderate or severe AE during the NMS-Nab Study can be included in the study
- •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.
- •Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
- •The patient is in good health as determined by medical examination and based on the investigator's judgement
排除标准
- •Patients with any of the following characteristics will be excluded from entering the study:
- •Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
- •Patients that experienced a drug-related SAE or had a (drug-related) moderate or severe AE during the NMS-Nab Study will be excluded in the study.
- •Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
- •Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement).
研究组 & 干预措施
Treatment Group
Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg
干预措施: Nabilone 0.25 mg (Drug)
结局指标
主要结局
Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3
时间窗: 6 months
Safety and tolerability will be evaluated with reference to the following: Number of subjects (%) who discontinue the study due to other reasons than an AE The reasons for discontinuation will be grouped in "discontinuation due to an AE" and "discontinuation due to other reasons". Both results will be provided separately.
Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale
时间窗: between V 1 and V 3 (6 months)
Change in aggregated data of the Columbia-Suicide Severity Rating Scale (C-SSRS). Different questions for suicidality with the possible answers yes or no. Yes represents a worse outcome. Count of participants with new suicidality is given.
Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3
时间窗: between V 1 and V 3 (6 months)
Changes in points of the: Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome.
AEs in PD Patients Taking Nabilone, Between V 1 and V 3
时间窗: 6 months
Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE)
Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3
时间窗: between V 1 and V 3 (6 months)
Changes in points of the: Hallucination item (1.2) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome. Participant count with a change in the hallucination item is reported.
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3
时间窗: between V 1 and V 3 (6 months)
changes in supine and standing blood pressure measurements (mmHg) Row titles: 1. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 1 2. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 3 3. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 1 4. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 3
Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3
时间窗: 6 months
Safety and tolerability will be evaluated with reference to the following: Number of subjects (%) who discontinue the study due to an AE The reasons for discontinuation will be grouped in "discontinuation due to an AE" and "discontinuation due to other reasons". Both results will be provided separately.
Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3
时间窗: between V 1 and V 3 (6 months)
Changes in points of the: Orthostatic hypotension item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome.
Subject Compliance in PD Patients Taking Nabilone.
时间窗: between V 1 and V 3 (6 months)
subject incompliance as per drug accountability (%)
次要结局
- Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone(from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion))
- Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3(from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion))
- Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
- Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3(between V 1 and V 3 (6 months))
研究者
Klaus Seppi, MD
Principal Investigator
Medical University Innsbruck