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
- 2 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 35
- 主要终点
- Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
研究概览
简要总结
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants 40 to 80 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.
研究组 & 干预措施
BHV-8000 20 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: Placebo (Drug)
Placebo
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo).
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 10mg (Drug)
Placebo
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo).
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 20 mg (Drug)
BHV-8000 10 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 10mg (Drug)
BHV-8000 10 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: Placebo (Drug)
BHV-8000 20 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 10mg (Drug)
BHV-8000 20 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 20 mg (Drug)
Placebo
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo).
Open-label Phase: Participants will receive BHV-8000.
干预措施: Placebo (Drug)
BHV-8000 10 mg
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.
Open-label Phase: Participants will receive BHV-8000.
干预措施: BHV-8000 20 mg (Drug)
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
时间窗: 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 DaT-SPECT scan from Baseline to Week 48(Baseline to Week 48)
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48(Baseline to Week 48)
- Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48(Baseline to Week 48)
- Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48(Baseline to Week 48)
- Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs(Baseline to Week 48)
- Number of participants with clinically significant laboratory abnormalities(Baseline to Week 48)
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase(Baseline to Week 48)
- Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 of the DB Phase(Baseline to Week 48)
- Change in DaT-SPECT scan from Baseline to Week 48 of the DB Phase(Baseline to Week 48)
- Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 of the DB Phase(Baseline to Week 48)
- Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs(Up to 96 weeks)
- Number of participants with clinically significant laboratory abnormalities(Up to 96 weeks)