(2R,5S)-TETRAHYDRO-5-(2-METHYL-1H-FURO[3,2-B]IMIDAZO[4,5-D]PYRIDIN-1-YL)-2H-PYRAN-2-ACETONITRILE for Early Parkinson's disease | Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Diagnosis of clinically significant central nervous system (CNS) disease other than PD."}
• {"criterion_text":"- Participants who are current smokers (defined as smoking [in any form, e.g., tobacco smoke, electronic cigarettes, etc.] )."}
• {"criterion_text":"- Treatment with PD medication(s)"}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater) from baseline to Week 48. MDS-UPDRS Part III is a 132-point scale; higher score = greater motor impairment."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by assessing change in CGI-S (Clinician Global Impression of Severity) from baseline to Week 48. CGI-S is a 7-point scale; higher = more severe."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in putamen ipsilateral to clinically most affected side from baseline to Week 48; lower uptake indicates progression."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured by change in PARCOMS-Function (composite of selected items from MDS-UPDRS Part II and PDQ-39) from baseline to Week 48; 100-point scale, higher = more dysfunction."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by counting unique participants with deaths, SAEs, AEs leading to discontinuation, and treatment-emergent moderate or severe AEs from baseline to Week 48."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by counting participants with treatment-emergent Grade 3 or 4 laboratory abnormalities from baseline to Week 48."}

Methods

• Study-specific country recruitment arrangements documents (K1) submitted per country (titles include 'Recruitment and informed consent procedure_Redacted') - implies local, site-based recruitment and informed consent procedures tailored per country.
• GP letter (Czechia) - 'K2_GP letter_CZE_Redacted' listed among recruitment materials, indicating engagement of general practitioners to refer potential participants.
• Study presentation materials and website text (Netherlands): 'K2_Recruitment material_BHV8000-301 study presentation_Redacted' and 'K2_Recruitment material_BHV8000-301_website text' indicate use of study presentations and website content to recruit.
• Vendor-supported patient reimbursement and travel arrangements for patients (noted: 'reimbursement and travel arrangements for the patients - for French, some Polish and some Spanish sites' by Scout Clinical) to facilitate participation at some sites.
• Country- and language-specific subject information sheets and informed consent forms (L1 documents) provided to participants in local languages, indicating site-level information distribution and consenting processes.

Austria

Earliest CTIS Part Ii Submission Date

30-10-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

53

Number Of Sites

2

Number Of Participants

25

Belgium

Earliest CTIS Part Ii Submission Date

06-11-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

39

Number Of Sites

4

Number Of Participants

25

Czechia

Earliest CTIS Part Ii Submission Date

27-10-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

49

Number Of Sites

3

Number Of Participants

25

France

Earliest CTIS Part Ii Submission Date

16-10-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

67

Number Of Sites

20

Number Of Participants

156

Germany

Earliest CTIS Part Ii Submission Date

26-11-2025

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

20

Number Of Sites

22

Number Of Participants

164

Italy

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

90

Number Of Sites

14

Number Of Participants

75

Portugal

Earliest CTIS Part Ii Submission Date

16-10-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

60

Number Of Sites

4

Number Of Participants

35

Spain

Earliest CTIS Part Ii Submission Date

17-11-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

35

Number Of Sites

14

Number Of Participants

70

Netherlands

Earliest CTIS Part Ii Submission Date

17-11-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

30

Number Of Sites

5

Number Of Participants

25

Poland

Earliest CTIS Part Ii Submission Date

26-11-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

26

Number Of Sites

16

Number Of Participants

113

Primary sponsor

Full Name

Biohaven Therapeutics Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

CRO/vendor (operational support; code 8 indicated)

Name

Premier Research International LLC

Responsibilities

Vendor management; vendor oversight and operational responsibilities

Name

Syneos Health Clinique Inc.

Responsibilities

Pharmacokinetic testing (PK) blood samples receipt, storage and analysis

Name

4g Clinical LLC

Responsibilities

IVRS/randomization system, study drug dispensing, accountability and randomization listing

Third parties

• {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Laboratory testing (listed assays include Creatine Kinase Isoenzymes; HCV by Quantitative NAAT; ANA with Titer and Pattern; Liver-Kidney Microsome-1 Antibody, IgG; F-Actin IgG; M2 IgG; HEV IgG & IgM)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Statistical/data review formatting (tables and listings) and providing unblinded data sets to DMC members","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Australia","full_name":"Cogstate Limited","duties_or_roles":"Provides rater training for the study and reviews data trends related to specific rating scale results","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Pharmacokinetic testing (PK) blood samples receipt, storage and analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Storage, distribution and shipment of samples to specialty laboratories; storing biomarker and pharmacogenetic samples collected throughout the study","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"Physical site of IMP importation for European Union","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"EU shipments; Varicella-Zoster IgG testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"CRO/vendor (responsibility code 8 indicated)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG vendor for ECG review and analysis; implementation and maintenance of the MDS-UPDRS in e-tablet format; data transfer from e-tablet to Biohaven and Cogstate","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Laboratory assays (CK Isoenzymes; HIV Confirmation Panel; HCV RNA Viral Load; HEV IgG; HEV IgM)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Provision of electronic data capture/eClinical systems","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"DRUGSCAN","duties_or_roles":"Urine Drug Screen with Amphetamine Confirmations","organisation_type":"Health care"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IVRS/randomization system, treatment assignment, study drug dispensing and accountability; generate randomization listing","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"Vendor management and operational support (multiple vendor management roles indicated)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Storage, distribution and shipment of samples to specialty laboratories; storing biomarker and pharmacogenetic samples","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central imaging vendor performing imaging review and analysis for MRI and DaT-SPECT scans","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement and travel arrangements for the patients (noted for French, some Polish and some Spanish sites)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Clintrex Research, LLC","duties_or_roles":"Vendor will train Investigators and Raters regarding the scale in clinical practice vs the clinical trial","organisation_type":"Industry"}
• {"country":"United States","full_name":"Navitas Life Sciences","duties_or_roles":"Contracted statistician working directly with the Biohaven team","organisation_type":"Industry"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central imaging vendor (duplicate entry in list for imaging review/analysis)","organisation_type":"Pharmaceutical company"}