A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 349
- 试验地点
- 53
- 主要终点
- Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [Time Frame: Up to 48 Weeks]. To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
研究概览
简要总结
To evaluate the efficacy of 2 dose levels of BHV-8000 compared to placebo by delaying the time to the first qualifying worsening event on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety Follow Up Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent
- •Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society(MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.
- •Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit
排除标准
- •Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.
- •Diagnosis of clinically significant central nervous system (CNS) disease other than PD.
- •Participants who are current smokers (defined as smoking [in any form, e.g., tobacco smoke, electronic cigarettes, etc.] ).
- •Treatment with PD medication(s)
- •Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.
结局指标
主要结局
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [Time Frame: Up to 48 Weeks]. To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [Time Frame: Up to 48 Weeks]. To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
次要结局
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 [Time Frame: Baseline to Week 48]. This objective is measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater). MDS-UPDRS Part III is a 132-point scale with a higher total score representing a greater degree of motor impairment.
- Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 [Time Frame: Baseline to Week 48]. To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in severity of a participant's illness as determined by the managing clinician. The CGI-S is a 7-point scale (1 - 7) with 7 representing the most extremely ill participants.
- Change in DaT-SPECT scan from Baseline to Week 48 [Time Frame: Baseline to Week 48]. To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in the putamen (assessing the activity of the dopamine transporters). Reduced uptake of the radiotracer is indicative of a decreased number of dopamine-secreting cells and suggestive of disease progression.
- Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 [Time Frame: Baseline to Week 48].To compare the efficacy of BHV-8000 compared to placebo.This objective is measured by changes in the Parkinson's Disease Composite Score-Function (PARCOMS-Function) score.The PARCOMS-Function is a composite of select items taken from the MDS-UPDRS Part II and the PDQ-39. The PARCOMS-Function is a 100-point scale with higher scores representing greater disfunction
- Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [Time Frame: Baseline to Week 48]. To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
- Number of participants with clinically significant laboratory abnormalities [Time Frame: Baseline to Week 48]. To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with treatment-emergent Grade 3 and 4 laboratory abnormalities.
研究者
Research and Development Medical Director
Scientific
Biohaven Therapeutics Ltd.