Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-01-01 @ 4:59 PM
Study NCT ID:
NCT06976268
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II", 'timeFrame': 'Up to 48 Weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48", 'timeFrame': 'Baseline to Week 48', 'description': '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.'}, {'measure': 'Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48', 'timeFrame': 'Baseline to Week 48', 'description': "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."}, {'measure': 'Change in DaT-SPECT scan from Baseline to Week 48', 'timeFrame': 'Baseline to Week 48', 'description': '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.'}, {'measure': "Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48", 'timeFrame': 'Baseline to Week 48', 'description': "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."}, {'measure': 'Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs', 'timeFrame': 'Baseline to Week 48', 'description': '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.'}, {'measure': 'Number of participants with clinically significant laboratory abnormalities', 'timeFrame': 'Baseline to Week 48', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Early Parkinson's Disease", "Parkinson's Disease", "Early onset Parkinson's Disease", "treatment naiive early Parkinson's Disease"], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent.\n* 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.\n* Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit\n\nKey Exclusion Criteria:\n\n* 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.\n* Diagnosis of clinically significant central nervous system (CNS) disease other than PD.\n* Participants who are current smokers (defined as smoking \\[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\\] )\n* Treatment with PD medication(s)\n* 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.'}, 'identificationModule': {'nctId': 'NCT06976268', 'briefTitle': "A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': "A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease", 'orgStudyIdInfo': {'id': 'BHV8000-301'}, 'secondaryIdInfos': [{'id': '2025-521113-13-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BHV-8000 10 mg', 'interventionNames': ['Drug: BHV-8000']}, {'type': 'EXPERIMENTAL', 'label': 'BHV-8000 20 mg', 'interventionNames': ['Drug: BHV-8000']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BHV-8000', 'type': 'DRUG', 'description': 'BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily', 'armGroupLabels': ['BHV-8000 10 mg']}, {'name': 'BHV-8000', 'type': 'DRUG', 'description': 'BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily', 'armGroupLabels': ['BHV-8000 20 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo taken once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-041', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-031', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-028', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-038', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-017', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-051', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-027', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-071', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-015', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-044', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-005', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-091', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-043', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-007', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'centralContacts': [{'name': 'Chief Medical Officer', 'role': 'CONTACT', 'email': 'clinicaltrials@biohavenpharma.com', 'phone': '203-404-0410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biohaven Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}