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.
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
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)
Parallel
BHV-8000 10mg
Drugtaken orally
BHV-8000 20 mg
Drugtaken orally
Placebo
Drugtaken orally
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
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.
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase
To evaluate the efficacy of BHV-8000 compared to placebo. 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 of the DB Phase
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 of the DB Phase
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 of the DB Phase
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© (assessing ability to complete daily activities). The PARCOMS-Function is a 100-point scale (0 - 100) with higher scores representing greater dysfunction.
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