A Phase 2/3 interventional study of BHV-8000 10mg and BHV-8000 20 mg in Parkinson Disease, sponsored by Biohaven Therapeutics Ltd.. Recruiting at 25 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Biohaven Therapeutics Ltd. · Phase 2/3, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 550 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
Drug: BHV-8000 10mg · Drug: BHV-8000 20 mg · Drug: Placebo
Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
Drug: BHV-8000 10mg · Drug: 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.
Drug: BHV-8000 10mg · Drug: BHV-8000 20 mg · Drug: Placebo
taken orally
taken orally
taken 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.
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 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.
Time frame: Baseline to Week 48
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.
Time frame: Baseline to Week 48
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.
Time frame: Baseline to Week 48
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.
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: Up to 96 weeks
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: Up to 96 weeks
Started May 2025 (actual). Primary completion is estimated for Aug 2027, 27 months after the start.
Of 22 phase 2/3 interventional studies under Parkinson Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 50. This study's planned 27 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Biohaven Therapeutics Ltd.