A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
Site-049
Birmingham, Alabama, United States
RECRUITINGSite-041
Los Angeles, California, United States
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.
Time frame: Up to 48 Weeks
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48
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.
Time frame: Baseline to Week 48
Change in Clinical Global Impression of Severity (CGI-S) from 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.
Time frame: Baseline to Week 48
Change in DaT-SPECT scan from 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.
Time frame: Baseline to Week 48
Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48
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Site-031
Farmington, Connecticut, United States
RECRUITINGSite-028
New Haven, Connecticut, United States
RECRUITINGSite-038
Atlantis, Florida, United States
RECRUITINGSite-017
Boca Raton, Florida, United States
RECRUITINGSite-051
Maitland, Florida, United States
RECRUITINGSite-027
Chicago, Illinois, United States
RECRUITINGSite-071
Boston, Massachusetts, United States
RECRUITINGSite-015
Farmington Hills, Michigan, United States
RECRUITING...and 5 more locations
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.
Time frame: Baseline to Week 48
Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
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.
Time frame: Baseline to Week 48
Number of participants with clinically significant laboratory abnormalities
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.
Time frame: Baseline to Week 48