A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Patient's change from baseline of score as measured by Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS; Part III), after 12 weeks of IPT803 administration.
研究概览
简要总结
The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Motor Assessments on regular PD treatment (Other)
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: IPT803 (Drug)
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Optional pharmacogenetic assessment (Genetic)
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Questionnaires (Other)
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Optional Blood-Oxygen-level Dependent functionalMRI (Other)
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: IPT803 (Drug)
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Optional pharmacogenetic assessment (Genetic)
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Questionnaires (Other)
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Optional Blood-Oxygen-level Dependent functionalMRI (Other)
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
干预措施: Motor Assessments before taking regular PD treatment (Other)
结局指标
主要结局
Patient's change from baseline of score as measured by Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS; Part III), after 12 weeks of IPT803 administration.
时间窗: Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Part III of the MDS-UPDRS (or motor examination) assesses the motor abilities in PD patients at the time of the visit. This part measures 18 motor examinations such as speech, facial expression, tremor, rigidity, finger tapping, pronation-supination movements of hands, leg agility, arising from chair, gait. The qualified rater must score 34 items from 0 to 4, where 0 indicates a normal situation and 4 indicates that PD interferes severely in carrying out the task. The total score, being the sum of all these items, can be between 0 to 136.
次要结局
- Patient's change from baseline of safety incidence as measured by the rate and severity of Treatment emergent adverse event (TEAEs).(Time zero equals baseline Visit 2 IPT803 first dose (Day 1) up to Visit 4 (Day 85))
- Patient's change from baseline of motor and non-motor outcomes as measured by Part I, Part II and IV subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).(From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85))
- The patient's change from baseline in disease severity as measured by the Parkinson's Disease Questionnaire (PDQ-39).(From Visit 2 (Day 1) up to Visit 4 (Day 85))
- Patient's change from baseline of fatigue as measured by the Fatigue Severity Scale (FSS).(From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85))
- Patient's change from baseline of sleep quality as measured by the Epworth Sleep Scale (ESS).(From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85))
- Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC).(From Visit 2 (Day 1) up to Visit 4 (Day 85))
- Patient's change from baseline in disease severity as measured by the Patient Assessment of Changes (PGAC).(From Visit 2 (Day 1) up to Visit 4 (Day 85))
- Cronbach α assessment of MPsQ(at Visit 1 (Day -14 to Day -7), Visit 2 (Day 1) Visit 4 (Day 85))
- Patient's change from baseline above or equal to the minimal clinically important difference (MCID) of the motor score as measured by Part II and III subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).(Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85))
- Patient's change from baseline above or equal to 30 % or above or equal to 50 % of the motor score as measured by Part II and III subscales of MDS-UPDRS.(Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85))